Anti-Depression Medication Drugs Found to be of Little Benefit

Anti-depression medication prescription drugs: Study finds that there was virtually no difference in the improvement scores for anti-depression drugs and placebo in patients with moderate depression and only a small but clinically insignificant difference among patients with very severe depression.

The findings also show that the effect for very severe depression patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to anti-depression drug medication.

Researchers from the U.K., America and Canada obtained data on all the clinical trials submitted to the FDA for the licensing of the new class of antidepressants -SSRIs. Selective serotonin reuptake inhibitors (SSRIs) are the newest antidepressants and include fluoxetine, venlafaxine, nefazodone, and paroxetine.

Although the US Food and Drug Administration (FDA), the UK National Institute for Health and Clinical Excellence (NICE), and other licensing authorities have approved SSRIs for the treatment of depression, some doubts remain about their clinical effectiveness.

Depression is a serious medical illness caused by imbalances in the brain chemicals that regulate mood. It affects one in six people at some time during their life, making them feel hopeless, worthless, unmotivated, even suicidal.

Doctors measure the severity of depression using the “Hamilton Rating Scale of Depression” (HRSD), a 17–21 item questionnaire. The answers to each question are given a score and a total score for the questionnaire of more than 18 indicates severe depression.

Mild depression is often treated with psychotherapy or talk therapy (for example, cognitive–behavioral therapy helps people to change negative ways of thinking and behaving).

For more severe depression, current treatment is usually a combination of psychotherapy and an antidepressant drug, which is hypothesized to normalize the brain chemicals that affect mood.

Before an antidepressant is approved for use in patients, it must undergo clinical trials that compare its ability to improve the Hamilton Rating Scale of Depression scores of patients with that of a placebo, a dummy tablet that contains no drug.

Each individual trial provides some information about the new drug's effectiveness but additional information can be gained by combining the results of all the trials in a “meta-analysis,” a statistical method for combining the results of many studies.

A previously published meta-analysis of the published and unpublished trials on SSRIs submitted to the FDA during licensing has indicated that these drugs have only a marginal clinical benefit.

On average, the Selective serotonin reuptake inhibitors (SSRIs) improved the Hamilton Rating Scale of Depression score of patients by 1.8 points more than the placebo, whereas the UK National Institute for Health and Clinical Excellence (NICE) has defined a significant clinical benefit for antidepressants as a drug-placebo difference in the improvement of the Hamilton Rating Scale of Depression score of 3 points.

However, average improvement scores may obscure beneficial effects between different groups of patients, so in the meta-analysis in this paper, the researchers investigated whether the severity of depression at the start of study affects antidepressant effectiveness.

The researchers obtained data on all the clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine.

They then used meta-analytic techniques to investigate whether the initial severity of depression affected the Hamilton Rating Scale of Depression improvement scores for the drug and placebo groups in these trials.

They confirmed first that the overall effect of these new generation antidepressants was below the recommended criteria for clinical significance.

Then they showed that there was virtually no difference in the improvement scores for drug and placebo in patients with moderate depression and only a small and clinically insignificant difference among patients with very severe depression.

The difference in improvement between the antidepressant and placebo reached clinical significance, however, in patients with initial Hamilton Rating Scale of Depression scores of more than 28 - that is, in the most severely depressed patients.

Additional analyses indicated that the apparent clinical effectiveness of the antidepressants among these most severely depressed patients reflected a decreased responsiveness to placebo rather than an increased responsiveness to antidepressants.

These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients.

The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication.

Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments for depression have been ineffective.

In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.

Reference:
Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, et al. (2008) Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration. PLoS Med 5(2): e45 doi:10.1371/journal.pmed.0050045. Copyright: © 2008 Kirsch et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License.

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Nutrition - Watermelon is an excellent source of arginine

Nutrition - Watermelon is an excellent source of arginine

Nutritional Benefits of Watermelon - Watermelon is an excellent food source of the amino acid citrulline, which the human body uses to make the amino acid arginine, which helps cells divide, wounds heal, and ammonia to be removed from the body.

Watermelon also contains plentiful amounts of the health-promoting antioxidant lycopene as an added bonus.

L-arginine increases the body's ability to produce Nitric Oxide when needed, and restores sexual function in impotent men. Studies have shown that oral arginine boosts immunity, fights cancer, promotes healing, protects and detoxifies the liver, improves thymus function and enhances male fertility.

The following research from the USDA Agricultural Research Service, 21 March 2007, by Erin Peabody, illustrates the Nutritional Benefits of Watermelon.

Nothing says you care like the gift of a small watermelon. At least that's the custom in China, where the offer of this red-fleshed cucurbit is considered a fine way to please a gracious host or ill friend.

Now scientists with the Agricultural Research Service (ARS) have found that there's far more to this gastronomic gesture than just tradition and good taste. In addition to containing plentiful amounts of the health-promoting antioxidant lycopene, watermelon is an excellent source of the amino acid citrulline.

And ARS researchers in Lane, Okla., and their collaborators have found that not only are watermelon's citrulline stores abundant--they're also readily usable. Their findings are reported in the current issue of the journal Nutrition.

The human body uses citrulline to make another important amino acid—arginine—which plays a key role in cell division, wound healing and the removal of ammonia from the body.

ARS plant physiologist Penelope Perkins-Veazie and nutritionist Julie Collins were interested in finding out just how bioavailable watermelon's citrulline is, since the fruit is one of few foods to contain high levels of it. Perkins-Veazie works at the ARS South Central Agricultural Research Laboratory in Lane, while Collins—previously based at the Lane laboratory—works at Eastern Oklahoma State College in Wilburton.

The two collaborated with amino acid expert Guoyao Wu at Texas A&M University in College Station.

After analyzing the arginine levels of volunteers who'd recently consumed differing amounts of concentrated watermelon juice, the scientists determined that ingesting the juice increased the volunteers' levels of plasma arginine - likely from conversion of citrulline.

Volunteers in the study completed one three-week stint during which they drank about three eight-ounce glasses of watermelon juice every day, and one three-week period of drinking about twice that much of the juice daily.

For comparison, other volunteers neither drank the juice nor ate watermelon or certain other foods that would skew study results.

Blood levels of arginine, synthesized in the body from the citrulline provided by the watermelon juice, were 11 percent higher in volunteers tested after three weeks on the three-glasses-a-day regimen (24 ounces), and 18 percent higher following the six-daily-glasses regimen (48 ounces), when compared to levels in samples from volunteers who didn't drink the watermelon juice.

Medical researchers are currently evaluating arginine as a possible treatment for high blood pressure, elevated glucose levels and the vascular complications associated with sickle-cell disease.

If such studies pan out, concentrated forms of watermelon could represent an all-natural amino acid source. The fruit's good-for-the-body lycopene is an added bonus.

Perkins-Veazie is now focused on finding an optimal way of extracting citrulline from watermelon.

Part of this article and photos courtesy of the Agricultural Research Service (ARS), the U.S. Department of Agriculture's chief scientific research agency. Used with permission.

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Lowering Triglycerides: DHA Lowers Triglycerides

Lowering Triglycerides: The benefits of fish oil include lowering the total amount of triglycerides in the blood. High blood levels of fats known as triglycerides may increase risk of heart disease. So may an unhealthy ratio of the good HDL cholesterol to the bad LDL cholesterol. Coronary heart disease that can result from these or other factors kills more Americans than any other disease.

Scientists with the Agricultural Research Service's Western Human Nutrition Research Center have seen triglyceride levels go down in volunteers who ate meals supplemented with a moderately high level of DHA, a polyunsaturated fatty acid. DHA is short for docosahexaenoic acid. The center, part of USDA's Agricultural Research Service, is in San Francisco, California.

Volunteers on a DHA-enriched regimen also showed an increase in HDL cholesterol, the kind known to protect against heart disease.

What's more, DHA may do this without unwanted side effects such as prolonged bleeding time or slower-than-normal blood clotting. These negative effects have been found in some studies of another polyunsaturated fat known as EPA, or eicosapentaenoic acid. EPA and DHA belong to the family of omega-3 fatty acids.

"From results with our small group of 10 volunteers," says ARS research chemist Gary J. Nelson, "it appears dietary DHA may be beneficial in altering an individual's risk of cardiovascular disease. But longer studies are needed before we can be certain."

The study was designed to help separate the effects of DHA and EPA.

"In fish oils, in particular," says Nelson, "these two polyunsaturated fats have been of intense interest in nutrition research since the 1970s. That's when studies suggested that the cardiovascular health of Greenland Eskimos might result in part from the predominance of oil-rich fish in their diets. Purported benefits include lowering the total amount of triglycerides in the blood.

"Fish and fish oils contain both DHA and EPA," Nelson says. "Of the two, EPA is predominant in fish that live in cold oceans. The presence of both EPA and DHA makes it difficult to determine which of the two is the major contributor to the health benefits claimed for fish or fish oil."

To help differentiate the effects of DHA and EPA, Nelson and colleagues used a natural oil extracted from golden algae that contains 40 percent DHA-but no EPA. This substance, according to Nelson, "has only recently become available as a source of purified DHA."

For the experiment, Nelson collaborated with chemists Darshan S. Kelley, Perla C. Schmidt, and Giovanni L. Bartolini, of the nutrition center, and David J. Kyle, vice president of Martek Corp. The Columbia, Maryland, company manufactures the DHA-rich oil used in the study.

Ten volunteers - healthy, nonsmoking males aged 20 to 39 - lived at the research center for the 4-month-study - the longest DHA experiment reported with in-residence volunteers. For the first 30 days, the volunteers ate a baseline diet that provided less than 50 milligrams a day of DHA.

For the remaining 90 days, 6 grams - about a teaspoon - of the DHA-rich oil was mixed with salad dressings or with bean, guacamole, or salsa dips served to six of the volunteers. That's about 100 times more DHA per day than most Americans consume. The other volunteers got safflower oil instead.

All meals for all volunteers were very low in EPA. To ensure that all the men received enough antioxidants, they took a 100-milligram vitamin E capsule every 5 days.

Meals featured familiar foods prepared with precision by the research center's dietary staff. One day's menus included, for instance, buttermilk pancakes, maple syrup, and sliced bananas for breakfast; canned peaches, sliced ham with jack cheese, lettuce, and mayonnaise on whole-wheat bread for lunch - with a salad of sliced cucumbers and french dressing on the side. A dinner of canned pineapple, roast chicken with teriyaki sauce, brown rice, and green beans was followed by chocolate cake as the evening snack.

Triglycerides in blood decreased by about 26 percent in volunteers on the DHA regimen. Their HDL cholesterol-the good kind-rose an average of 9 percent.

The DHA-supplemented group also showed an increase of about 69 percent in apoprotein-E. This compound carries cholesterol from peripheral tissues back to the liver for breakdown and excretion. Increased apo-E, Nelson says, "has not been reported in other DHA or EPA studies with humans."

Nelson and co-workers looked at several indicators of normal bleeding and clotting. They found no significant differences in these measures before or after the high-DHA diet. "That's unlike fish oils," says Nelson. "They have been shown to increase bleeding times. Fish oils have also been shown to inhibit aggregation of blood platelets needed to form clots."

DHA and EPA are essential to good health. Our bodies need fats to carry fat-soluble vitamins like A, D, and K; to make steroid hormones; to keep skin healthy; and to perform other biochemical chores.

But health officials today generally recommend that fats take up no more than 30 percent of each day's total calories. Saturated fats-ones like butter and lard that stay solid at room temperature-should make up no more than 10 percent.

Reference:
Marcia Wood, Agricultural Research Service Information Staff. USDA, ARS.

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Cardiovascular Health/Heart Disease News

NHLBI Research Highlights at American Heart Association’s Scientific Sessions.

Findings on Women and Menstrual Cycling, Weight Gain Prevention Intervention in African American Girls, Impact of Breastfeeding on Adult HDL Cholesterol Levels

November 8, 2007

At the American Heart Association’s 2007 Scientific Sessions in Orlando held November 4 - 7, scientists supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health present the latest research findings, including:

Studies on the relationship between physical activity and a stable body mass index (BMI),

New insights in hormone therapy and coronary artery disease in women,

And how bystander use of automated external defibrillators during cardiac arrest more than doubles survival chances.

Breastfeeding boosts adult HDL “good” cholesterol levels.

Data collected from third generation participants in the Framingham Heart Study revealed that breastfeeding in infancy is associated with lower body mass index (BMI) and increased HDL cholesterol in adulthood.

Overall 26 percent of participants had been breastfed as infants – as reported by their mothers – and those participants were found to have lower BMI and increased levels of HDL in adulthood.

Upon adjustment for BMI, the difference in HDL between breastfed and bottle-fed participants was lessened.

Breastfeeding was not associated with other examined adult cardiovascular disease risk factors.

NHLBI spokesperson: Caroline Fox, M.D. Framingham Investigator: Nisha Parikh, M.D., Framingham, MA. Contact Dr. Parikh at (617) 388-0017 or [email protected].


Bystanders using automated external defibrillators greatly increase survival.

Cardiopulmonary resuscitation (CPR) combined with bystander use of an automated external defibrillator (AED) more than doubled the chances of surviving out-of-hospital cardiac arrest compared with using CPR alone.

Researchers from the Resuscitations Outcomes Consortium (ROC), a network of 11 urban and rural communities in the United States and Canada involved in studies of pre-hospital emergency care, analyzed data gathered over one year on patients suffering out-of-hospital cardiac arrest.

Findings confirm that AEDs used by bystanders before arrival of emergency personnel significantly improves survival over CPR alone.

Bystanders included lay volunteers, police, and healthcare workers. The findings reinforce results from the Public Access Defibrillation trial, which showed that training and equipping lay volunteers to use an AED in community settings doubled the number of survivors after out-of-hospital cardiac arrest compared to training in CPR alone.

Based on national statistics related to out-of-hospital cardiac arrest, researchers estimated that bystander CPR plus use of an AED in the United States and Canada saves 522 lives a year, or more than one life per day.

This number could be greatly increased with the installation of more public access defibrillators.

NHLBI spokesperson: George Sopko, M.D. ROC Investigator: Myron L. Weisfeldt, M.D., Johns Hopkins University. Dr. Weisfeldt can be reached at (410) 955-6642 or [email protected].


Physical activity helps maintain weight.

Maintaining high levels of physical activity from young adulthood into middle age increases the odds of maintaining a stable weight during that time period, according to a new analysis of the CARDIA (Coronary Artery Risk Development in Young Adults) study.

The odds of maintaining a stable body mass index (BMI) over the twenty years from young adulthood into middle age were increased by 38 percent for each increase of 30 minutes per day of vigorous physical activity recorded at the start of the study.

Men and women ages 18-30 were enrolled in CARDIA and followed through seven exams over 20 years.

Participants who consistently maintained the higher level of activity – more than 30 minutes of vigorous activity each day – were more than twice as likely to maintain a stable BMI over 20 years.

NHLBI spokesperson Gina Wei, M.D. CARDIA Investigator: Arlene Hankinson, Northwestern University. Contact Arlene Hankinson at [email protected].



Women with irregular menstrual periods are more likely to have heart attack or chest pain.
Women with self-reported irregular menstrual cycles have a greater frequency of diabetes and adverse cardiovascular events, suggesting that coronary artery disease or associated risk factors might be linked to ovarian dysfunction.

Researchers from the Women’s Ischemia Syndrome Evaluation (WISE) study used diagnostic coronary angiography to determine the presence or severity of blocked coronary arteries in approximately 700 postmenopausal women and compared the results between women with a history of irregular menstrual cycles and those who had regular cycles.

During the six year study, they found that both groups were equally likely to have coronary artery disease. However, women with a history of menstrual irregularity but who did not have blocked arteries had an increased risk of heart attack and angina compared to women with regular cycles.

Women with a history of irregular menstrual cycles were also more likely to have experienced menopause at a younger age and to have had surgical menopause (removal of their ovaries or uterus).

NHLBI spokesperson: George Sopko, M.D. WISE Investigator: B. Delia Johnson, Ph.D., University of Pittsburgh. Contact Dr. Johnson at (412) 624-7256 or [email protected].


Cardiovascular effects of hormone therapy linked to type of menopause and age.
There is growing evidence that younger women have fewer adverse cardiovascular effects – or perhaps have less risk of heart disease – from hormone therapy compared to older women who use hormone therapy.

The first prospective study to show cardiovascular effects of hormone therapy using diagnostic coronary angiography supports the theory that a woman's age when she begins hormone therapy matters.

However, cardiovascular benefits in younger women appear to apply only to women who undergo natural menopause.

In the Women’s Ischemia Syndrome Evaluation (WISE) study of about 650 postmenopausal women, those who experienced natural menopause and who began hormone therapy before age 45 had lower rates of coronary artery disease compared to their peers who began hormone therapy after age 45 or who did not take hormone therapy.

Use of hormone therapy did not affect heart disease rates among surgically menopausal women regardless of age.

NHLBI spokesperson: George Sopko, M.D. WISE Investigator: B. Delia Johnson, Ph.D., University of Pittsburgh. Contact Dr. Johnson at (412) 624-7256 or [email protected].



Obesity prevalence in African American girls remains high. Are intervention programs effective?
Researchers with the NHLBI-funded GEMS (Girls Health Enrichment Multisite Studies) project evaluated the effectiveness of an intervention program in preventing excessive weight gain among girls ages 8-10 years.

Three hundred predominately low-income 8-10 year old African American girls were randomly assigned to either a behavior intervention program focusing on improving diet and promoting physical activity, or a control program promoting self-esteem.

Both groups were offered weekly meetings for 14 weeks, followed by monthly contacts. After two years, girls in the intervention group exhibited a slower and more normal weight gain and had nearly 50 percent lower gain in body mass index than girls in the control group.

Those in the intervention group also decreased their total daily caloric intake by 162, increased their vegetable intake and water consumption, and decreased consumption of sweetened beverages.

Researchers did not observe any differences in physical activity between the groups.

NHLBI spokesperson: Charlotte Pratt, Ph.D. GEMS Investigator: Bob Klesges, Ph.D., St. Jude Children's Research Hospital. Contact Dr. Klesges at (901) 283-6074 or [email protected].

Source: NHLBI News Room. Used with permission.

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High Blood Pressure - Reduce Carbohydrates

More protein and less carbs in your diet naturally remedies high blood pressure. Compared with a diet containing more carbohydrates, a diet with greater protein lowers blood pressure, LDL “bad” cholesterol, and triglycerides.

Replacing Some Carbohydrates with Protein and Unsaturated Fat May Enhance Heart Health Benefits: The types of food eaten in an effort to cut down on saturated fat may make a difference in reducing heart disease risk, according to a study of people with either high blood pressure or prehypertension.

The study was supported by the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health.

Investigators evaluated three diets that follow the principles of NHLBI’s DASH (Dietary Approaches to Stop Hypertension) eating plan with some modifications.

One diet emphasized carbohydrates, another diet emphasized protein, and the third emphasized monounsaturated fat. They reported that while all three diets lowered blood pressure, improved cholesterol levels, and reduced ten-year risk of heart disease by as much as 16 to 21 percent, two of these modified diets were even more effective in reducing some risk factors and estimated risk for heart disease than the diet richer in carbohydrates.

The Optimal Macronutrient Intake Trial to Prevent Heart Disease (OmniHeart) study will be presented today in Dallas at the American Heart Association annual conference, and also published in the November 15 issue of the Journal of the American Medical Association.

These new OmniHeart study results do not represent new guidelines for healthy eating and the proportions of carbohydrate, protein, and fat for all three diets are all within the ranges recommended by the U.S. Dietary Guidelines for Americans and other national public health organizations.

Earlier in 2005, the U.S. Department of Health and Human Services incorporated NHLBI’s DASH eating plan as one option within the U.S. Dietary Guidelines.

All of the studied diets are a vast improvement over the typical American diet which can be high in saturated fat and low in essential nutrients, according to NHLBI Director Elizabeth G. Nabel, M.D.

“This study builds on an established body of evidence that shows following a dietary pattern lower in saturated fat, such as the DASH eating plan, can go a long way toward improving overall heart health. With these new data, we have been able to incorporate even more flexibility into the DASH eating plan by providing additional options for people seeking to improve their heart health through healthier eating,” said Nabel.

The study results reinforce the health benefits of following a DASH-type eating plan and suggests that tweaking certain components within that plan—protein and unsaturated fat—may yield benefits for specific risk factors.

Compared with the study diet containing more carbohydrates, the diet with greater protein:

• lowered blood pressure, LDL “bad” cholesterol, and triglycerides, and

• lowered HDL “good” cholesterol.

The diet with more unsaturated fat, primarily monounsaturated fat:

• lowered blood pressure and triglycerides,

• raised HDL, and

• did not lower LDL.

By providing all daily meals to 164 men and women for 41 days for each diet, researchers evaluated the three diets to determine whether replacing calories from saturated fat with calories from protein or unsaturated fat was better than replacing those calories with carbohydrate.

Saturated fat is known to raise blood cholesterol, and public health officials recommend that it make up less than 10 percent of daily calories for healthy individuals and less than 7 percent of daily calories for individuals with heart disease risk factors.

Participants were age 30 or older and had either high blood pressure or prehypertension at the time of enrollment.

“These new findings open the door to further research on the diets’ long-term effects and the ability of people to follow these diets,” said Eva Obarzanek, Ph.D., NHLBI research nutritionist and study co-author.

The OmniHeart study diets differed from each other in several ways:

• The diet emphasizing carbohydrates contained 58 percent of calories from carbohydrates and 15 percent of calories from protein. In addition, it contained 21 percent of calories from unsaturated fat. The other two diets reduced carbohydrate to 48 percent of calories.

• The diet emphasizing protein increased the protein to 25 percent of calories. To increase protein, mostly plant sources, such as beans and nuts, were used, although poultry, egg substitutes, and fat-free or low-fat milk products were also used. Like the carbohydrate diet, it contained 21 percent of calories from unsaturated fat.

• The diet emphasizing unsaturated fat used primarily fats and oils rich in monounsaturated fat, like olive oil, to increase unsaturated fat to 31 percent of calories. Like the carbohydrate diet, it contained 15 percent of calories from protein.

“Our results emphasize the impact that diet can have on blood pressure and cholesterol levels, two of the major heart disease risk factors,” said Lawrence Appel, M.D., M.P.H., of Johns Hopkins Medical Institutions and lead investigator of the OmniHeart study.

The OmniHeart study did not address other types of diets such as the Atkins or Mediterranean diet.

The OmniHeart study was conducted at Johns Hopkins Medical Institutions and Brigham and Women’s Hospital. The first participants started the protocol in 2003, and the last participants ended the study in June 2005.

NHLBI has long recommended changes in lifestyle, including following a heart healthy eating plan to reduce risk factors for heart disease. The DASH eating plan was developed through a series of clinical studies that showed that a dietary pattern rich in fruits, vegetables, fat-free or low-fat milk and milk products, and whole grains substantially reduced blood pressure and had other beneficial effects.

The eating plan also includes lean meats, poultry, fish, legumes, and nuts and is low in saturated fats, cholesterol, sodium, and sweets and added sugars.

The new DASH Eating Plan menus are included in the book A Healthier You published by the U.S. Department of Health and Human Services. This newly released book is based on the 2005 Dietary Guidelines for Americans.

Source: National Heart, Lung, and Blood Institute (NHLBI)

Stilnox, Ambien Side Effects

The Sydney Morning Herald in Australia reported on 4 March 2007 that a woman who fell 30 metres to his death from a high-rise unit balcony may have been sleepwalking under the influence of Stilnox. The coverage prompted over 40 readers to contact the newspaper with their own accounts of Stilnox related automatism and the drug is now under review by the Adverse Drug Reactions Advisory Committee. (Wikipedia).

The updated warning released by the Therapeutic Goods Administration (TGA) now mentions less common side-effects as "rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour".

It also warns of "sleep walking, driving motor vehicles, preparing and eating food, making phone calls or having sexual intercourse" while asleep and on the drug. "People experiencing these effects have had no memory of the events," the warning states. (The Sydney Morning Herald 28/11/2007).

Concerns are rising over the controversial sleeping drug Stilnox, with 300 callers swamping a consumer information line detailing dangerous side-effects, including sleep walking over high-rise balconies. Dr Moses, a pharmacist for 20 years, said she had never been so inundated with calls detailing adverse reactions relating to a single drug. (couriermail.com.au March 26, 2007).

Several sleeping pill users have moved to mount legal action after reports of bizarre and dangerous sleepwalking behaviour while taking the controversial drug Stilnox. The move comes as Stilnox complaints to the national drug hotline rose to 500, with fresh reports of sleepwalkers crashing cars, falling off balconies, smoking, painting and having sex after popping a pill. (theage.com.au, April 2, 2007).

The family of a Sydney woman, who died after plunging 20 metres from the Harbour Bridge, have blamed the controversial sleeping pill Stilnox for her death. Security footage shows 27-year-old Mairead Costigan walking groggily across the cycle path and climbing onto a ledge before she fell. (LIVENEWS.com.au).

Stilnox is sold as Ambien is the U.S.

"I have a number of clients who, the only way they get through the mediation or counselling sessions with their husbands is Ambien," said a Manhattan divorce lawyer. "They knock themselves out and then they're on automatic for the 45 minutes”.

At a recent party, actress Helen Hunt's boyfriend, novelist Matthew Carnahan, remembered his Ambien-induced sleep: "You have strange dreams. If you try to stay awake, you make phone calls you don't remember-it's like living a horrible blackout." (The New York Observer).

“The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, according to emerging medical case studies that describe how the drug’s users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands.” (The New York Times (March 14, 2006).

On a lighter note – from The New Yorker:

Sorpresa con Queso Ingredients: 7 bags Cheetos, 17 to 19 glasses tap water, 5 mg Ambien. Place Cheetos bags in cupboard. Take Ambien, fall asleep. Wait 2-3 hours, then sleepwalk to kitchen, tear cupboard doors off hinges in search of Cheetos…eat contents of all 7 bags… Icebox Melange…Take Ambien, fall asleep…sleepwalk to kitchen. Devour everything in refrigerator…(Paul Simms, Shouts & Murmurs, "The Ambien Cookbook," The New Yorker, July 31, 2006, p. 34).

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger language concerning potential risks.

These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.

• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labelling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

FDA News, March 14, 2007. Accessed 20 February 2008.

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Causes of Alzheimer’s and the Role of Blueberries

Although the exact cause of Alzheimer’s is not completely understood, experts have recently identified one mechanism involving the insufficient breakdown and recycling of amyloid protein in the brain.

Agricultural Research Service neuroscientist James Joseph and colleagues published an Alzheimer’s disease model study in Nutritional Neuroscience.

They studied mice that carried a genetic mutation for promoting increased amounts of amyloid beta, a protein fragment found within the telltale neuritic plaque, or “hardening of the brain,” seen in Alzheimer’s disease.

James Joseph heads the Neuroscience Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.

Experts have recently identified one mechanism involving the insufficient breakdown and recycling of amyloid protein in the brain. That mechanism is both genetic and physiological.

In those individuals, normally harmless amyloid protein turns into fragments of amyloid beta, which build up as plaque in the brain rather than being escorted into cellular recycling. That action leads to cell death and weakened neuronal communication.

In the mouse study, beginning at age 4 months - early adulthood - half the brain-plaqued group was fed a diet that included blueberry extract for 8 months. The other half was fed standard rat chow and so was a control group of mice that didn’t carry the amyloid-plaque mutation.

At 12 months - early middle age - all groups were tested for their performance in a maze.

The brain-plaqued mice that were fed the blueberry extract performed as well as the healthy control mice and performed much better than their brain-plaqued peers fed standard chow.

A look at the plaqued brains of both the blueberry-fed and chow-fed mice after death revealed no difference in the number of brain plaques in either group. “Amyloid-beta-induced plaques are only one aspect of Alzheimer’s disease,” said Agricultural Research Service neuroscientist James Joseph. “But the fact that we saw a diet-induced behavioral difference, despite a similarity in plaque density in both these animal groups, is significant.”

The team found increased activity of a family of enzymes called “kinases” in the brains of the amyloid-plaqued mice that were fed blueberry extract. Two kinases found in particular, ERK and PKC, are important in mediating cognitive function, such as converting short-term memory to long-term.

“These kinase molecules are involved in signaling pathways for learning and memory,” says Joseph. “It could be that the increased kinase activity within the plaque-ridden brains of the blueberry-fed mice enhanced the signaling in certain receptors.”

Reference:
USDA, Agricultural Research Service

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Ageing research in the UK: The 10 Commandments for Healthy Ageing

Our society is experiencing unprecedented demographic change. Improvements in health care and living conditions together with a decrease in fertility rates, have contributed to the ageing of the population and a severe demographic redistribution. According to the national census of 2001, for the first time in the UK there are more people over age 60 years than under age 16 years.

However, a large proportion of people over age 60 suffer from chronic illnesses or disabilities. In contrast to the UK, in some other countries (e.g. Japan) it has been found that extended lifespan does not necessarily translate into increased morbidity.

Coping with the impacts of these demographic changes is one of the greatest challenges for the 21st century. However, aging research in the UK is largely fragmented, underrepresented, poorly coordinated and lacks adequate funding support.

In 2005, The House of Lords Select Committee on Science and Technology undertook an inquiry, chaired by Lord Sutherland of Houndwood, to evaluate the scientific aspects and current situation of ageing research in the UK. Among other findings, the inquiry reported "the attempts at coordination so far made under the aegis of the research councils are woefully inadequate. The image we have is of a series of ill-thought-out initiatives which have long titles, short lives, vague terms of reference, little infrastructure, and no sense of purpose. A radical reorganisation is essential".

This inadequacy identified by the enquiry and the current demographic changes were the primary incentives for convening a 'Spark Workshop' -a two-day meeting, in which researchers from different areas across industry, charities, government and academia, share knowledge, explore potential novel concepts, and assess possibilities for future activities.

The aims of the workshop were (1) to evaluate the future of ageing research in the UK, and (2) to formulate a vision for action.

The workshop, held in May 2006, was jointly convened by the Funders' Forum for Research on Ageing and Older People (FFRAOP, or Funders' Forum) – a multi-agency alliance with a remit of coordinating ageing research in the UK- and the Corporate Research division of Unilever -a multinational foods, home and personal care company with a longstanding interest in promoting healthy aging.

The 10 commandments for ageing research in the UK

It is urgent that the UK adopts an integrated, multidisciplinary approach to ageing research, which recognizes its great importance as a societal and governmental priority.

As it is identified in the House of Lords' report, the science of ageing in the UK is unstructured, under-funded and poorly coordinated. Since the 'ownership' of ageing science in the U.K. is at present dispersed and ambiguous, it is essential to re-structure and organize ageing research under a clear representation that could secure the funds needed to guarantee its full development.

The efforts made for instance in Canada in the last few years, suggest that the creation of a 'virtual' ageing institute may contribute to create a stronger ownership and focus on ageing research, facilitate a multi-disciplinary approach to ageing science and assist young scientists to identify and develop career opportunities in the field.

However, independent to the model adopted, it is evident that ageing research in the UK urgently requires a clearly defined organisational structure to guarantee its successful implementation and the realisation of its main goal: a population living longer, healthier and happier.

These and other conclusions reached during this 'Spark Workshop' have been summarized in a list of ten points, which constitute the backbone of a vision for action that could help to guarantee the successful implementation of ageing research in the UK:

1. Ageing is a highly differentiated and malleable process. Therefore, the commitment must be to develop interventions that can affect the ageing process or the experience of ageing in order to extend healthy life expectancy, independence and well-being in old age.

2. Investments in aging research should be significantly increased as they are likely to produce immense gains to both the economy and society, in particular to the quality of life, productivity and self-sufficiency of the rapidly growing older population group

3. Society must recognise that improving the quality of life, of older people, including the promotion of active ageing and the eradication of ageism, is one of the biggest challenges of the 21st century. This should translate into an integrated governmental policy for research on ageing as a key driver of QOL improvements.

4. Ageing research should reflect the complexity of the ageing process and integrate different dimensions of research into human healthy ageing, including the biological mechanisms and the socio-economic, cultural and psychological determinants of the ageing process

5. Healthy ageing research should concentrate on early, reversible stages of pathological conditions. As many lifestyle-related chronic diseases share common pathways of early dysregulation (e.g. cardiovascular disease, alzheimer’s disease), the development of markers, diagnostic techniques and interventions that can be applied to prevent late stage disease is fundamental

6. Ageing research should build on and expand existing longitudinal cohorts. These are critical to understand longevity and must combine genetic, socio-demographic and environmental aspects. It is crucial that future efforts embrace the role of genetics in aging research given the variability of responses of individuals to drugs, nutrients and lifestyles due to different polymorphisms

7. Ageing research should pursue 'best practice' early interventions by creating an evidence base for translation to society, by engaging directly with its end users and, in particular, by ensuring that older people are a key reference point.

8. Research to inform the development and uptake of information technology, assistive technology and inclusive design must be implemented in the construction and design of products, homes, urban environments, public buildings and transportation systems to eradicate potentially disabling environments to functionally-limited older populations

9. The void in clear leadership, funding and representation of ageing research in the UK must be addressed. In particular, additional resources must be allocated to under-funded areas of aging research (e.g. healthy ageing) to complement existing commitments to research aimed towards end-point chronic disease

10. It is critical that an overall ageing research portfolio is managed as a single entity across the contributing disciplines, which individually and collectively enhance understanding about the determinants and interventions that affect active ageing.

Extracted from: Franco OH, Kirkwood TBL, Powell JR, Catt M, Goodwin J, Ordovas JM, van der Ouderaa F. Ten commandments for the future of ageing research in the UK: a vision for action. BMC Geriatrics 2007, 7:10 (3 May 2007) doi:10.1186/. © 2007 Franco et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0).

Cholesterol Lowered with a Diet High in Soy Protein

Study shows the cholesterol lowering effects of soy protein in men’s diets. Soy protein can be an important ally in lowering cholesterol, according to new findings from a study conducted at the Children's Nutrition Research Center in Houston, Texas.

This research, published in the October issue of American Journal of Clinical Nutrition, may also explain why previous studies have produced conflicting evidence concerning the merits of soy protein.

The study results suggested soy protein can enhance the effects of a diet designed to lower cholesterol. This holds true for men whose levels are in the safe cholesterol range and those above it.

The Children's Nutrition Research Center is jointly managed by the Agricultural Research Service, the chief research agency of the U.S. Department of Agriculture, and Baylor College of Medicine.

The study involved 26 men, 20 to 50 years of age, half of whom had high cholesterol. All the men went on the National Cholesterol Education Program's Step I diet to lower their cholesterol - but with a special twist. Half of the subjects were getting their protein from soy; half from meat.

After a 10-to-15 week "washout" period, the two groups swapped diets; those receiving their protein from soy switched to meat, and vice versa.

While both groups of men experienced improved blood cholesterol on both diets, those receiving soy improved more than those receiving meat protein, regardless of age or weight.

Low density lipoprotein-cholesterol (LDL-C) is associated with increased heart-disease risk.

Men with cholesterol problems who went on the meat-protein diet dropped their LDL- cholesterol 8 percent, but their LDL-cholesterol dropped 13 percent on the soy-protein version. The percentage for men with "safe" LDL-cholesterol levels was smaller - 5 percent for meat and 11 percent for soy.

Researchers suggested that previous studies finding little benefit from soy may not have included a "washout period" or adequately monitored subjects' diets. The men in this study ate only pre-packaged meals prepared at the center.

Source: Jill Lee, Agricultural Research Service, U.S. Department of Agriculture. Photo courtesy ARS, USDA.

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Diabetes in Dogs and Cats

Middle aged to older dogs are the more prone to developing diabetes. Even though cats of all ages are susceptible older cats are more prone to developing cat diabetes. Good nutrition is necessary to keep their weight under control and stabilize blood sugar levels.

In general, most dogs and cats with diabetes will get insulin injections at home. Vets recommend high fiber, low carbohydrate food which also has added chromium to boost the effects of the insulin. Chromium is effective in improving the effectiveness of insulin. It is also helpful in balancing cholesterol levels and reducing the risk of heart disease.

Humans have more in common with man's best friend than they probably realize, according to an assistant professor of clinical sciences at Kansas State University.

Pets such as cats and dogs are just as susceptible to diabetes as their human counterparts are, said Thomas Schermerhorn of the College of Veterinary Medicine.

He said warning signs of diabetes in pets include excessive drinking, or polydipsia; excessive urination, or polyuria; and weight loss. In more severe cases, Schermerhorn said, symptoms include vomiting or diarrhea.

"It's not until pets have made an accident in the house or lose weight, for instance, that owners come in," Schermerhorn said. "The symptoms are pretty straightforward. Owners can bring their pets in, and we'll do blood and urine tests."

Schermerhorn said that the types of diabetes in dogs and cats vary but are similar to those detected in humans. Dogs with diabetes, he said, are most comparable to humans who have Type I diabetes, which Schermerhorn characterized as being typically insulin-dependent. Cats, meanwhile, show more characteristics of a Type II diabetic, in which the human's diabetes usually is linked to obesity.

Schermerhorn said the only way a cure can be found is through years of laboratory and clinical research, not simply through clinical practice, where veterinarians make deductions through their textbooks and individual patients.

"The disease will never be addressed until we do species-specific research," he said. "The cure will come years down the road but probably will come in the form of transplantation."

Until the day when the research produces a cure, Schermerhorn said, diabetes in pets is treatable in a similar manner to humans.

"In general, most dogs and cats with diabetes will get insulin injections at home," Schermerhorn said. "Some pet owners are scared to do it at first but become good at it."

Thomas Schermerhorn, assistant professor of clinical sciences, is involved in research that may be applied to diabetes in dogs and cats, as well as humans.

"We know what goes wrong in diabetes, but we don't know why it goes wrong. Our approach looks at what is normal and compares that to an abnormal cell to find out where the problem is," Schermerhorn said.

Schermerhorn's research focuses on the functions of the beta cell, the cell in the pancreas that secretes insulin. There are thousands of beta cells, each one with tiny granules containing small amounts of insulin. The granules go to the cell membrane and stay there until receiving the proper stimulus, Schermerhorn said.

"Each granule has a tiny amount of insulin, each one secreting insulin resulting in a normal response after eating a meal. This lowers blood sugar and keeps it under control," Schermerhorn said.

The beta cells Schermerhorn studies are altered so they are capable of reproducing outside the body yet can still secrete insulin. These cells act exactly like beta cells that live inside normal animals and humans, Schermerhorn said.

Schermerhorn began by looking at inhibitors of insulin and found that once the beta cell was stimulated to secrete insulin, it could then be modified by inhibitors. The inhibitors tend to decrease cell response to glucose, the principal nutrient in a diet that stimulates secretion.

Norepinephrine, an inhibitor sometimes called noradrenaline, can inhibit secretion profoundly and has direct effects on the proteins in the final stage of granule release, Schermerhorn said.

"Norepinephrine somehow alters or impairs three crucial proteins from coming together. This either disables the granule from being secreted, or prevents the granule from coming to the membrane and forming a protein complex," Schermerhorn said.

Diabetes is the second most common endocrine problem of older cats and one of the top three endocrine problems of older dogs.

Weight loss, excessive water consumption and excessive urination are common symptoms in dogs or cats indicating they may need to be tested for diabetes, Schermerhorn said.

"Usually, the dog or cat maintains an excellent appetite although they do not gain weight, but instead they may lose weight," Schermerhorn said.

"We're hoping to use a physiological approach to learn about beta cell function and provide a basis for the study of abnormal beta cell function that might contribute to the development of diabetes," Schermerhorn said.

Schermerhorn's research is in collaboration with Geoffrey Sharp, department of molecular medicine in the College of Veterinary Medicine at Cornell University, and Philine Wangemann, department of anatomy and physiology at K-State's College of Veterinary Medicine.

The research project is funded by a grant from the National Institute of Diabetes, Digestive and Kidney Diseases of the National Institutes of Health.

Reference:
K-State Media Relations, K-State's news service.

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Vitamin E and Heart Disease

This news release was issued in July 2005. I am posting it together with some of my own comments to possibly help clarify the Vitamin E issue.

Women’s Health Study Finds Vitamin E does not Protect Women from Heart Attack, Stroke, or Cancer: Vitamin E supplements do not protect healthy women against heart attacks and stroke, according to new results from the Women’s Health Study, a long-term clinical trial of the effect of vitamin E and aspirin on both the prevention of cardiovascular disease and of cancer.

(Not all supplements are equal - See my article Vitamin E – Cancer, Alzheimer’s and Heart Disease - Alpha or Gamma?).

The vitamin E results of the Women’s Health Study are published in the July 6 issue of the Journal of the American Medical Association. In addition to the cardiovascular disease findings, the study authors report that there was no effect of vitamin E on total cancer or on the most common cancers in women – breast, lung, and colon cancers.

The Women’s Health Study was funded by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute of the National Institutes of Health.

“This landmark trial has given women and their physicians important health information. We can now say that despite their initial promise, vitamin E supplements do not prevent heart attack and stroke.

Instead, women should focus on well proven means of heart disease prevention, including leading a healthy lifestyle and controlling risk factors such as high blood pressure and high cholesterol,” said NHLBI Director Elizabeth G. Nabel, M.D.

The Women’s Health Study was conducted between 1992 and 2004. The participants were 39,876 healthy women age 45 years and older who were randomly assigned to receive 600 IU of Vitamin E or placebo and low-dose aspirin or placebo on alternate days. The participants were followed for an average of 10.1 years.

The aspirin results published last March found no benefit of aspirin (100 mg every other day) in preventing first heart attacks or death from cardiovascular causes in women but did find a reduced risk of stroke overall, as well as reduced risk of both stroke and heart attack in women aged 65 and older.

In recent years, there has been a great deal of public and scientific interest in the potential of antioxidant vitamins like vitamin E to reduce the risk of cardiovascular disease. Laboratory and animal research suggested that vitamin E might prevent the accumulation of fatty deposits inside arteries, which would reduce the chance of clogged and blocked arteries.

Other large observational studies have also suggested that people who eat foods high in vitamin E or take supplements have a lower risk of coronary heart disease.

(Kevin Flatt's comment: Eating foods high in vitamin E supply eight separate compounds. Some members of the vitamin E family are called tocopherols. These members include alpha tocopherol, beta tocopherol, gamma tocopherol, and delta tocopherol. Other members of the vitamin E family are called tocotrienols.

These members include alpha, beta, gamma, and delta tocotrienols. Both groups are all blended together in plants and animals, which is why the best form of vitamin E comes from your food.

Also, many people take supplements containing this wide variety of vitamin E groups which are usually referred to as “mixed tocopherols” or “mixed tocotrienols” in supplements.

Too much Alpha tocopherol can actually hinder the absorption of other types of vitamin E).

Although several clinical trials conducted prior to the Women’s Health study found little cardiovascular benefit from vitamin E, these trials were shorter and primarily studied individuals with cardiovascular disease or CVD risk factors. The intent of the Women’s Health Study was to provide a long-term look at the effects of vitamin E supplementation among healthy women.

Participants in the Women’s Health Study were monitored for major cardiovascular “events” – a combination of nonfatal heart attack, nonfatal stroke, or cardiovascular death. By the end of the study, participants in the vitamin E group had 482 such events compared to 517 in the placebo group. However, this difference was not statistically different.

For the individual cardiovascular events, the study findings were:

• Nonfatal heart attacks: 184 in the vitamin E group versus 181 in the placebo group – not a statistically significant difference.
  


• Nonfatal strokes: 220 in the vitamin E group versus 222 in the placebo group – not statistically significant.

Study investigators also found no significant effect of vitamin E on total deaths (deaths from all causes). By the end of the study, there were 636 deaths in the vitamin E group compared to 615 in the placebo group.

Although total deaths were unaffected by vitamin E, there was a significant 24 percent reduction in cardiovascular deaths among all women taking the vitamin (106 deaths in the vitamin E group versus 140 in the placebo group). In another positive finding, women 65 and older taking vitamin E had a 26 percent decrease in heart attacks and cardiovascular deaths, but not strokes.

“These intriguing findings deserve further study. But they were not part of the primary aim of the study – to look at the effect of vitamin E on overall cardiovascular disease, which includes heart attack, stroke, and cardiovascular death. Additionally, previous studies of vitamin E in patients with heart disease have not shown any benefit for cardiovascular deaths. At present, we cannot recommend vitamin E for prevention against cardiovascular disease or cancer,” said lead investigator I-Min Lee, MBBS, ScD of Brigham and Women’s Hospital.

The study finding of a decrease in major cardiovascular events among women age 65 years and older is relatively unique, added Dr. Lee. “Almost all previous trials have not reported findings by age. If other current trials provide age-related results, these additional data will help clarify the Women’s Health Study results of benefit among the women aged 65 years and older,” she said.

Overall, the results were not affected by a study participant’s menopausal status, use of hormone therapy, body mass index, alcohol intake, or physical activity. The study found no significant side effects among women taking vitamin E except for an increase in nosebleeds, which was likely due to chance, as there was no increase in risk of other types of bleeding, including hemorrhagic stroke.

According to the 1999-2000 National Health and Nutrition Examination Survey, an estimated 13.5 percent of women in the U.S. take vitamin E supplements, although it is not known how many are taking the vitamin to prevent heart disease and stroke.

NHLBI’s Dr. Nabel encouraged women to learn more about proven ways to prevent heart disease, the number one killer of women. The Heart Truth (www.hearttruth.gov.), NHLBI’s program to increase women’s awareness of the dangers of heart disease, offers resources and information on leading a healthy lifestyle.

Reference:
National Heart, Lung, and Blood Institute NHLBI.

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Orange Peels Lower Cholesterol and Triglycerides

Research shows that orange peels, traditionally discarded as non-value waste, lower cholesterol and triglycerides naturally. Polymethoxylated flavones in orange oil demonstrated significant cholesterol and triglyceride lowering in hamsters.

Agricultural Research Service (ARS) scientists have recently learned that a compound found in orange oil decreases blood serum levels of the protein responsible for low-density lipoprotein (LDL) that's a major cholesterol carrier.

John A. Manthey, a chemist at the Winter Haven lab, is known for his work on citrus flavonoids in peel byproducts. His work has mainly focused on polymethoxylated flavones, or PMFs, which typically occur at very high concentrations in orange oil, especially in residues left behind after orange-oil processing. Orange-oil residues have traditionally been discarded as non-value wastes.

In Florida, about 700,000 tons of dried peel solids are left over from squeezing around 150 million boxes of juice oranges every year, on average. Most of this processing waste is now sold for livestock feed at little or no profit to citrus processors.

Manthey's research has shown that the PMFs decrease blood serum levels of apoprotein B, the structural protein of LDL cholesterol. Too much circulating LDL cholesterol can slowly lead to atherosclerosis, clogged arteries and eventual heart attacks and strokes. These problems are accelerated by chronic, low-grade inflammation in the blood vessels.

For the past eight years, Manthey has collaborated with KGK Synergize of London, Ontario, Canada, a company that specializes in research to identify health-promoting compounds and focuses on nutraceuticals. Sometimes called functional foods, nutraceuticals are natural, bioactive chemical compounds with disease-preventing or medicinal properties. Nutraceuticals are being commercially produced by food, pharmaceutical, and herbal and dietary supplement industries.

The original collaboration between ARS and KGK Synergize involved studies of anticancer properties of citrus PMFs, but it then expanded into investigations of the compounds’ abilities to lower LDL cholesterol in animals.

Subsequent ARS feeding trials with hamsters demonstrated significant cholesterol- and triglyceride-lowering actions of PMFs: At 1 percent of the diet, PMFs lowered blood plasma levels of LDL, very-low-density lipoprotein (VLDL) cholesterol, and triglycerides by 30-40 percent.

A diet of 0.25 percent PMFs resulted in smaller decreases in LDL and VLDL cholesterol, but decreases in triglycerides were as large as those occurring at higher PMF doses.

These findings are the basis of human trials, currently being conducted by KGK, on the cholesterol-lowering properties of PMFs.

Manthey’s previous research also provided evidence of anti-inflammatory actions of PMFs in animals—another mechanism by which the compounds may protect against cardiovascular disease. Products containing cardioprotective PMFs are being developed by some private companies.

Similar studies of cardioprotection have been started by Manthey and postdoctoral researcher Kanjana Mahatannahee on flavonoids and related phenols in select Florida-grown tropical fruits—such as mamey, guava, dragon fruit, and carambola. Scientists have found these to be extremely high in phenolic antioxidants.

Source: Alfredo Flores, Agricultural Research Service Information Staff. U.S. Department of Agriculture.

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Cholesterol Lowering Benefits of Plant Sterols

A recent study shows that plant extracts containing sterols are one of many natural remedies for high cholesterol. People who already eat a low-fat diet to reduce cholesterol might lower it more by consuming a soybean extract with high levels of substances called plant sterols, according to preliminary new research, Agricultural Research Service Administrator Floyd P. Horn said today.

Volunteers in the research study ate the soybean sterols as an ingredient in low and reduced-fat salad dressings.

"The research is preliminary but offers new evidence that soybean and other plant extracts containing sterols can increase the cholesterol-lowering benefits of a healthy low-fat diet," said Horn. "People who want to reduce their cholesterol through diet may see better results by including low-fat foods having added sterols as part of their low-fat diet."

The study's lead researcher, chemist Joseph T. Judd of USDA's Agricultural Research Service in Beltsville, Md., presented the findings today at the Experimental Biology 2000 meeting in San Diego.

Horn said cholesterol reductions nearly doubled in the study's 53 men and women volunteers, when their low-fat diet included two daily servings (4 tablespoons total) of salad dressing containing soybean sterols. The volunteers consumed the sterols--2.2 grams or about ½ teaspoon--daily for three weeks of the six-week study period.

Judd led the study at ARS' Beltsville Human Nutrition Research Center. The study was partly funded by Lipton through a cooperative research agreement with ARS. A manuscript is being prepared for submission to a peer-reviewed scientific publication.

Plant sterols are ingredients in a number of fat-based foods on the market including salad dressings and margarines. Potential dietary benefits of plant sterols, including cholesterol reduction, have been studied for decades.

Judd said the Beltsville study was unique in examining plant sterols as an ingredient in low-fat foods and as part of a tightly controlled low-fat diet. Most studies have looked at sterol effects in higher fat foods.

The soybean extracts used in the Beltsville study are compounds known as sterol esters. Their molecular structure is similar to cholesterol. Judd said sterol esters most likely lowered the volunteers' cholesterol by limiting its intestinal absorption.

The volunteers began the study with their levels of "bad" (LDL) cholesterol in the mildly elevated range. For six weeks, they ate all their meals at the Beltsville center. For three of those weeks, their daily diet included 2.2 grams of soybean sterols as an ingredient in salad dressing.

On the low fat diet alone - without plant sterols - the volunteers' total and "bad" cholesterol levels dropped 7.3 and 8.4 percent, respectively.

With the sterols, the reductions were nearly double: 14.1 and 18.2 percent.

"I was surprised at the magnitude of the effect," said Judd, with the Beltsville center's Diet and Human Performance Laboratory. "And, the volunteers' levels of 'good' (HDL) cholesterol stayed the same."

Overall fat intake in the study diet amounted to 32 percent of total calories. A 36-percent fat diet is about the average for American adults.

Curiously, five of the 53 volunteers lowered their cholesterol only during the part of the study that included sterol esters.

"Many people with high cholesterol," Judd noted, "do not respond to a low-fat diet alone and rely on cholesterol-lowering drugs. The question is, could dietary plant sterols also help these kinds of people?"

Judd conducted the study with physiologist David Baer of the Diet and Human Performance Laboratory; chemist Beverly Clevidence, who leads the center's Phytonutrients Laboratory; and nutrition scientists Shirley Chen and Gert Meijer of Lipton.

"We want to learn how plant sterols could affect cholesterol in people eating their own diets," Judd said. "So, we plan to extend our investigation of plant sterols to study about 100 free-living volunteers who will eat their usual diets instead of a controlled diet."

The sterols used in the study already occur - in low concentrations - in many raw and refined vegetable-based foods including vegetable oils. A typical American diet provides approximately 0.25 g of plant sterol per day. "It would be impractical to try to consume 2.2 grams a day of sterols from refined oils or other foods," Judd said.

Reference: Jim De Quattro, Agricultural Research Service, U.S. Department of Agriculture.

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Natural Cholesterol Remedies – Fruit and Veggies

A natural remedy to raise HDL cholesterol levels may be a higher consumption of fruit and vegetables, which are high in vitamin C. The higher your HDL cholesterol, the less bad cholesterol you'll have in your blood. Many doctors are now beginning to pay more attention to HDL cholesterol.

HDL cholesterol takes up excess cholesterol from cells and returns it to the liver, making the cells more receptive to the LDL cholestorol particles. This prevents the LDL cholesterol particles from staying in the arteries and joining with bad company - the oxidizers. When that happens, an artery-clogging plaque may form.

Paul P. Jacques and colleagues at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston looked into whether increasing vitamin C intake could help.

They recruited 138 men and women aged 20 to 65 to take either a 1-gram vitamin C supplement or a look-alike placebo every day for 8 months. To prevent any bias, neither teachers nor volunteers knew who was getting which pill.

Jacques, an epidemiologist, Ernst J. Schaefer, a physician, and colleagues Sandra Sulsky, Gayle Perrone, and Jennifer Jenner wanted to see if extra vitamin C would or wouldn't raise HDL cholesterol.

Many studies - both experimental and observational - have shown a positive correlation between the amount of vitamin C circulating in people's blood and their HDL cholesterol levels. But other studies have found no relationship, explains Jacques. So the subject has remained controversial.

The results of this study were also mixed, depending on how much ascorbic acid (vitamin C) the volunteers had running in their veins to begin with.

"We saw no effect of the vitamin C supplements on HDL cholesterol among the volunteers who began the study with blood plasma ascorbic acid levels at or above 1 milligram per deciliter," he says. "But there was a significant effect among a subset of the volunteers who began with plasma ascorbic acid (vitamin C) levels below 1 mg/dL."

Their HDL cholesterol levels increased an average 7 percent, he says, while total cholesterol/HDL cholesterol - a ratio used to evaluate cholesterol status - dropped 8 percent.

About one-third of the volunteers fell into the group with low plasma ascorbic acid.

Nationwide, it's a higher percentage, says ARS vitamin C expert Robert A. Jacob.
"Among U.S. adults who don't take supplements containing vitamin C, more than half have plasma ascorbic acid levels below 1 mg/dL."

But it's easy to increase vitamin C levels without supplements, Jacob adds, noting that 75 to 80 percent of U.S. adults don't take them regularly.

"Eating five servings of fruits and vegetables a day will put blood levels above the 1 mg/dL mark. These foods also provide other protective substances besides antioxidants. And many protective substances in plant foods are still being discovered - so they're not in supplements.

"Even three to four servings of the top vitamin C sources would probably do," Jacob says. Citrus, potatoes, broccoli, cauliflower, strawberries, papayas, and many dark, leafy greens are excellent sources of the vitamin.

Jacques says the 43 people who began the study with low plasma ascorbic acid also had significantly lower HDL cholesterol levels than those who had at least 1 mg/dL of ascorbic acid circulating through their bodies.

The low-ascorbic-acid group consumed more fat and obviously less vitamin C, based on a lengthy questionnaire on the volunteers' living habits. And their triglycerides, total cholesterol, and LDL cholesterol - the artery-damaging kind - were significantly higher.

But none of these risk factors for heart disease improved with vitamin C supplements, which is another reason to get vitamin C from fruits and vegetables.

Reference: Judy McBride, Agricultural Research Service, U.S. Department of Agriculture. Photo courtesy ARS, USDA.

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