Optimum Health & Wellness

Tranexamic Acid (Lysteda) Approved for the Treatment of Heavy Menstrual Bleeding

2009-11-13T16:23:00.001-07:00

The U.S. Food and Drug Administration today approved tranexamic acid (Lysteda tablets), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.

“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron (Pfizer), and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).

Use of tranexamic acid while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take tranexamic acid only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

Tranexamic Acid (Lysteda) is manufactured by Xanodyne Pharmaceuticals of Newport, Ky, an integrated specialty pharmaceutical company with both development and commercial capabilities focused on pain management and women's healthcare. The company, founded in 2001 markets a portfolio of prescription pharmaceuticals and a line of prenatal vitamins.

Potential Health and Safery Concerns Results in FDA Probe of Caffeinated Alcoholic Beverages

2009-11-13T12:08:00.001-07:00

The US Food and Drug Administration (FDA) today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.

In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Annual EU healthcare index puts The Netherlands in “uncontested leadership”

2009-09-28T09:18:00.006-07:00

The Netherlands win the 2009 Euro Health Consumer Index (EHCI), for the second year in a row - the first time this happens since the EHCI started in 2005 - and with an outstanding margin. Nevertheless, Denmark keeps its runner-up position from last year.

Besides the Dutch and Danish system there is a small group of strong performers: Iceland, Austria and Switzerland.There are general improvement trends among most of the measured healthcare systems, with examples of reform making impact not only in Netherlands but in Ireland and the Czech Republic as well.

There is continuous decline in the Spanish, Portuguese and Greek healthcare systems which do not keep up with the improvement rate one can find in countries like the Netherlands, Denmark or Ireland. Large parts of Eastern and Central Europe seem to be affected by the financial crisis.

The HCP research director, Dr. Arne Bjornberg, comments on the EHCI 2009 outcomes: "As the Netherlands are expanding their lead among the best performing countries, the Index indicates that the Dutch might have found a successful approach. It combines competition for funding and provision within a regulated framework. There are information tools to support active choice among consumers.

The Netherlands have started working on patient empowerment early, which now clearly pays off in many areas.Johan Hjertqvist, President of Health Consumer Powerhouse, commented: "With patient mobility growing around Europe, there is a strong need for transparency exposing the pros and cons of the national healthcare systems. The EU intends to introduce a crossborder care scheme which requires significantly better information to patients. This years´ measurement indicates that forward-looking governments start using healthcare information and choice to engage patients in the decision-making, building a pressure from below for improvement".

EHCI categories
The EHCI 2009 groups 38 indicators of quality into six categories: Patient rights and information, e-Health, Waiting time for treatment, Outcomes, Range and reach of services provided and Pharmaceuticals. Each sub-discipline is weighted for importance to provide the overall Index score.The individual category leaders were as follows:

Patient rights and information: Denmark
e-Health: Denmark, Netherlands
Waiting time for treatment: Albania, Belgium, Germany, Switzerland
Outcomes: Sweden
Range and reach of services provided: Belgium, Luxembourg, Sweden
Pharmaceuticals: Denmark, Netherlands

The 2009 EHCI is developed in co-operation with the European Commission DG Information Society and Media and works under the auspices of the Swedish EU Presidency.

Obesity Causes More than 124,000 New Cancers a Year in Europe

2009-09-25T15:56:00.001-07:00

According to estimates from a new modeling study, at least 124,000 new cancers in 2008 in Europe may have been caused by excess body weight. The proportion of cases of new cancers attributable to a body mass index of 25kg/m2 or more were highest among women and in central European countries such as the Czech Republic, Latvia, Slovenia and Bulgaria.

The lead author of a study called ‘Incident cancer burden attributable to excess body mass index in 30 European countries’, published in the International Journal of Cancer, Dr Andrew Renehan, told oncologists and other medical professionals gather together in Berlin, Germany during the combined 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology: “As more people stop smoking and fewer women take hormone replacement therapy, it is possible that obesity may become the biggest attributable cause of cancer in women within the next decade.”

Dr Renehan, who is a senior lecturer in cancer studies and surgery at the University of Manchester (UK), and his colleagues in the UK, The Netherlands and Switzerland, created a sophisticated model to estimate the proportion of cancers that could be attributed to excess body weight in 30 European countries. Using data from a number of sources including the World Health Organization and the International Agency for Research on Cancer, they estimated that in 2002 (the most recent year for which there are reliable statistics on cancer incidence in Europe) there had been over 70,000 new cases of cancer attributable to excess BMI out of a total of nearly 2.2 million new diagnoses across the 30 European countries.

The percentage of obesity-related cancers varied widely between countries, from 2.1% in women and 2.4% in men in Denmark, to 8.2% in women and 3.5% in men in the Czech Republic. In Germany it was 4.8% in women and 3.3% in men, and in the UK it was 4% in women and 3.4% in men.

Then, the researchers projected the figures forward to 2008, taking into account what was known about shifts in the distribution of BMI, the dramatic decline in women’s use of hormone replacement therapy (HRT) from 2002 onwards following research that showed it increased the risk of breast cancer, and the wider use of PSA screening for prostate cancer in men.

They found that the number of cancers that could be attributed to excess body weight increased to 124,050 in 2008. In men, 3.2% of new cancers could be attributed to being overweight or obese and in women it was 8.6%. The largest number of obesity-related new cancers was for endometrial cancer (33,421), post-menopausal breast cancer (27,770) and colorectal cancer (23,730). These three accounted for 65% of all cancers attributable to excess BMI.

“I must emphasize that we are trying not to be sensationalist about this,” said Dr Renehan. “These are very conservative estimates, and it’s quite likely that the numbers are, in fact, higher.”

The number of new cases of obesity-related esophageal cancer was particularly high in the UK relative to the rest of Europe. “This country accounts for 54% of new cases across all 30 countries,” said Dr Renehan. “This may be due to synergistic interactions between smoking, alcohol, excess body weight and acid reflux – and is currently an area where research is required.”

Until 2002 when HRT use dropped dramatically following the results of the Women’s Health Initiative Trial (USA) that showed an increased risk of breast cancer in women taking HRT, Dr Renehan said that HRT masked and diluted the effects of obesity on the incidence of breast cancer. “In women who used HRT it wasn’t clear what proportions of breast cancers were caused by HRT or by obesity. In women who don’t take HRT, the effect of obesity was much clearer. Now that far fewer women are using HRT, it is much easier to see the effect of obesity on the incidence of breast cancer, and also on endometrial cancer. Consequently, the proportions of these cancers attributable to obesity have increased.”

Dr Renehan said that although European countries were taking steps to tackle the obesity epidemic, this study underlined the urgency of the task and the scale of the problems caused by increasingly overweight populations.

“The overall size of the burden of increasing cancer incidence should inform health policy. For example, it is clear that, in both relative and absolute terms, obesity-related cancer is a greater problem for women than for men. At a country level, it is a greater problem for central European countries like the Czech Republic, whereas it is less of a problem in France and Denmark. Similarly, obesity-related esophageal cancer seems to be a substantial and unique problem in the UK.

“The study also identifies priorities for research into certain cancers, namely endometrial, breast and colorectal cancers. In the face of an unabating obesity epidemic, and apparent failure of public health policies to control weight gain, there is a need to look at alternative strategies, including pharmacological approaches.”

Dr Renehan’s own research is trying to relate these epidemiological findings back to the biological mechanisms that are at work. His research uses the observed interactions between excess BMI and cancer risk to guide questions in the laboratory.

For more information:

ECCO15 – ESMO 34 Abstract no: 327, Oncopolicy session: Drug and lifestyle mediated prevention initiatives in Europe. Thursday 11.15-12.15 hrs CEST (Hall 3)

Survey Shows that Diabetic Nerve Pain Significantly Impacts Daily Activities

2009-09-18T22:13:00.006-07:00

In a new online survey conducted among 553 men and women, 18 and older who have either type I or II diabetes and are suffering from diabetic nerve pain in the United States, eighty-five percent said that their pain was one of the top three most bothersome complications of their diabetes.

Despite the fact that people with diabetic nerve pain recognize the condition's impact on their lives and eighty-four percent of those surveyed said they have discussed the condition with a healthcare provider, just slightly less than half of respondents (49 percent) were treating their pain.

The survey was fielded as part of a new educational campaign, "Take the Next Step," which is designed to help people with diabetes recognize the symptoms of painful diabetic peripheral neuropathy (pDPN) and proactively talk to their healthcare professional about incorporating the treatment of pDPN into their overall diabetes care, which may include blood sugar control, diet, pain management, exercise or other changes in lifestyle. The initiative is supported through a sponsorship by Pfizer Inc.

Taking Control of Your Diabetes (TCOYD), a leading non-profit organization dedicated to educating people about diabetes, and Kim Lyons, personal trainer and nutritionist featured on NBC's hit show, "The Biggest Loser," are participating in this campaign to raise awareness of pDPN, one of the most common and debilitating complications of diabetes. "Take the Next Step" features an activity program developed by Lyons to demonstrate activities that are appropriate for people with diabetes and help people with pDPN understand how increasing their activity level can help them control their pain.

"Optimal blood sugar control has been shown to prevent the onset and delay the progression of pDPN and ease its symptoms," said Steven Edelman, MD, Founder and Director of the not-for-profit 'Taking Control of Your Diabetes' and Professor of Medicine, University of California at San Diego. "Given the debilitating impact of pDPN, such as on a person's ability to be physically active and to fall asleep at night, treating the pain can really make a difference for these patients and help them get back to normal daily activities which in turn can help them better manage their diabetes."

Many patients are unaware of treatment options.
Of the people surveyed, almost two-thirds (64 percent) said that their nerve pain interfered with the daily activities that matter to them. The most common activities that respondents said were impacted by their pain were exercising (76 percent), falling asleep (71 percent) and spending time with or caring for family (68 percent). Of the more than half of those surveyed who were not being treated (51 percent), less than a third (32 percent) were aware of treatments that are approved to treat the condition.

Currently, nearly 24 million Americans suffer from diabetes. Approximately 20 percent of people with diabetes experience painful diabetic peripheral neuropathy, most commonly caused by poorly controlled blood sugar levels that result in nerve damage over time. Symptoms of pDPN may include burning, throbbing or painful tingling in the feet or hands.

The pain associated with the condition can become extremely debilitating, affecting patients' everyday activities such as the motivation needed to exercise and be active and the ability to fall asleep. Difficulty maintaining an active lifestyle can hamper patients' ability to control their weight, an important key to diabetes management. Treatment guidelines point to the unique nature of pDPN and the need for specialized treatment, which can include prescription treatment for the pain.

"I was motivated to be a part of this campaign because I've seen the benefits of activity for people who suffer from pDPN," said Kim Lyons. "I know that for people with this kind of pain, engaging in physical activity might seem daunting at first, but people will be amazed to see that taking small steps towards increasing activity level can make a big difference."

Prevention, early diagnosis and aggressive treatment are critical
People with diabetes can develop nerve pain at any time, but the risk is greater the longer a person has suffered from diabetes, with the highest rates among those who have had the condition for at least 25 years. In the early stages of nerve damage, some people have no symptoms, or may have numbness or tingling in the feet. These symptoms can be mild at first and because nerve damage can occur over several years, these cases may go unnoticed until the nerve damage progresses and becomes painful, sometimes leading to painful diabetic peripheral neuropathy (pDPN).

A number of prescription medications are approved by the U.S. Food and Drug Administration (FDA) to help relieve the specific symptoms of pDPN. These medications can play an important role in helping to reduce the pain associated with this condition. Over-the-counter pain medicines such as acetaminophen and ibuprofen are frequently used, but have not been specifically approved by the FDA to treat painful diabetic peripheral neuropathy.

For more information:

Diabetes Pain Help

Introducing a More Powerful WIN CoQ10™

2009-09-16T21:45:00.012-07:00

Vitaelin Nutraceuticals today introduced the new and improved WIN CoQ10™ packs a powerful punch with its new size.

WIN CoQ10™ contains the most advanced, form of CoQ10 available, ubiquinol, which plays a vital role in energy production. Additionally, this ubiquinol form is an active antioxidant protecting the body’s cells from damage caused by oxidative stress and free radicals. Experience new sustained energy and promote your overall health with WIN CoQ10™ .

WIN CoQ10™ is a nutritional supplement containing ubiquinol, the reduced form of coenzyme Q10, which has been shown to help lower blood pressure and improve symptoms related to heart disease and may help improve brain functioning. Additionally, WIN CoQ10™ may help restore coenzyme Q10 which can be lost when taking certain medications to lower cholesterol levels, such as statins, and dietary supplements containing red yeast rice. Maintaining coenzyme Q10 levels are essential as coenzyme Q10 is a critical component of energy metabolism at the cellular level. WIN CoQ10™ 's protective effect on the heart may slow the aging of cells associated with the cardiovascular system.

WIN CoQ10™ 's 100% natural, high-absorption formula is far superior to most CoQ10 supplements because they primarily consist of ubiquinone which isn’t as easily absorbed by the body. Studies show WIN CoQ10™ absorption rate is 8 times higher than supplements with ubiquinone and maintains higher levels of CoQ10 in the blood over time. It took 2400mg of ubiquinone to reach the same level of CoQ10 in the bloodstream with only 300mg of WIN CoQ10™ 's ubiquinol formulation.

WIN CoQ10™ may:

Support and maintain energy production
Promote heart health
Help prevent free radical damage
Help protect against oxidative stress
Maintain healthy, normal blood pressure
Help manage the entire circulatory system
Promote a healthy immune system
Maintain healthy neurological function

Studies show WIN CoQ10™ formula additionally supports periodontal tissue well-being, musculoskeletal health and the body’s natural defense system.

Now More Powerful
WIN CoQ10™ now includes a new, patent-pending crystal free technology, WIN-CFT™, which provides a clearer appearance and improves CoQ10’s absorption rate within the body. The solution featuring D-Limonene oil helps better protect ubiquinol from oxidization. When oxidization does occur, ubiquinol crystallizes resulting in a cloudy, opaque appearance. By keeping the CoQ10 solubilized, things start to look much clearer and the required amount of oil solution is halved, providing us with a smaller soft gel, all while improving CoQ10 bioavailability within the body.

WIN CoQ10™ now also contains a versatile antioxidant called alpha lipoic acid (ALA) to help extend CoQ10’s energy production benefits.Though its appearance is a little different, the new and improved WIN CoQ10™ is still filled with 50 mg of the most advanced, high-absorption form of CoQ10 available with WIN-CFT™ maximizing its absorption rate.

For more information and to order, click here.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, mitigate or prevent any specific disease or class of diseases.

Obesity Driving America's Healthcare to a Tipping Point

2009-09-09T19:04:00.006-07:00

The Obesity Society, a leading scientific organization dedicated to the study of obesity, and other steering committee members of the Strategies to Overcome and Prevent (STOP) Obesity Alliance, and two former US Surgeons General, join together today to develop effective recommendations to urge policymakers to act on the inclusion of obesity as the largest and most urgent driving factor in healthcare reform.

The two most recent Surgeons General of the United States, David Satcher MD, PhD and Richard H. Carmona, MD, MPH, respectively 16th and 17th US Surgeons General, jointly urged policymakers to take direct action on obesity and its associated chronic diseases by including obesity as a key element in healthcare reform.

"Health reform will succeed only if we address obesity and the chronic diseases it causes," said Robert Kushner, MD, President of The Obesity Society. "Obesity is the number 1, most serious health issue facing the country. It is also the largest single driver of our increasing healthcare costs and we need to address it now."

More than one third of US adults -- more than 72 million people -- and 16 percent of US children are now estimated to be overweight or obese. Obesity and overweight are associated with several chronic health risks and conditions, including: diabetes, heart disease, stroke, hypertension, some types of cancer, sleep apnea, osteoarthritis, and gallbladder disease. Furthermore, the medical costs of obesity are now estimated at more than $147 billion per year.

The Obesity Society supports the four targeted recommendations for effective healthcare reform issued by the STOP Obesity Alliance at the meeting held today at the Newseum in Washington, DC:

Standardized and effective clinical interventions, flowing from evidence-based guidelines, such as those approved by the National Heart, Lung and Blood Institute (NHLBI), that include acknowledging the health benefits of five to ten percent sustained weight loss to
aid and support those individuals who are currently overweight or obese achieve improved health.
Enhanced use of clinical preventive services to monitor health status and help prevent weight gain, especially for individuals who are already overweight and are at risk of becoming obese.
Effective, evidence-based community programs and policies that encourage and support healthy lifestyles, focus on health literacy, address health disparities, and represent a significant investment in population-based prevention of obesity.
Coordinated research efforts to build the evidence for all three of the above elements, continuously improving quality of care, bolstering our understanding of what does and does not work in various settings, and helping to translate the scientific research into practice
recommendations for real-world clinical settings and communities.

"These recommendations are designed to improve the dialogue and interventions around obesity. Successful reform will address clinical treatment, prevention, community programs and research to reverse the medical burden of obesity," said Dr. Kushner. "Lending our support to the STOP Obesity Alliance recommendations will also bring us one more step closer to providing a health system that can effectively lessen the grip of obesity on our society."

For more information:

OBESITY, Halting the Epidemic by Making Health Easier (Centers for Disease Control)
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, NHLBI.
Eric A. Finkelstein, Justin G. Trogdon, Joel W. Cohen, William Dietz, [Health Affairs 28, no. 5 (2009): w822-w831 (published online 27 July 2009; 10.1377/hlthaff.28.5.w822)]

Simple ABCs of Weight Loss and Fitness: Advice From Someone who Knows

2009-09-08T08:55:00.009-07:00

Modern American society is filled with easily accessible fatty foods, a growing obesity epidemic and a general lack of healthy living. In his new book,Lose Weight, Feel Great: How I Lost Over 60lbs. with the Help of a Personal Trainer,author Kevin Given tells of his personal struggles with obesity, how he lost over 60 pounds with the help of a personal trainer, and how others can change their lifestyles and bodies as well.

Says Given 'This book is different from other weight loss books because it is my personal story of how I overcame the obstacle of obesity. I also avoid going into unnecessary detail. I find that most problems with weight loss books are that they get bogged down with details on how certain things work. My book cuts to the chase and makes it simple. "If you do this, then this is what will happen."

Given Continues: "If you eat certain foods, this is how they will affect your system. If you do a certain exercise; for example dumb-bell curls, then this is what will happen; your biceps will develop. There are no unnecessary details here that will only slow you down. In my book you will find the simple ABCs of weight loss and fitness."

Given had ongoing issues with his weight for over 20 years with many failed attempts at change. He tried numerous fad diets that never worked, so he then decided to hire a personal trainer to aid him in losing weight and keeping it off for good. Now a certified personal trainer himself, Given hopes to help others through a combination of historical knowledge of human health, personal testimony, exercises and fitness techniques, nutrition, and other information vital to weight loss and good health.

While the use of this book and practicing a healthy lifestyle are certainly reliable ways to lose weight and get in shape, Given also believes the aid of a personal trainer helps immensely in this journey toward the ideal you.

"If the military sent a soldier to basic training with only an army manual and no guidance, that soldier wouldn't learn much! How many soldiers would get up at four or five AM without the drill sergeants going through the hall with a stick and a garbage can banging as loudly as he or she can? Who would be motivated to do pushups if the drill sergeant didn't yell, "Drop and give me twenty"? Just as the soldier is guided to his peak performance during army basic training, so an individual seeking to get into better shape will be guided by the personal trainer into reaching his/her goal", Given explains.

Ongoing Safety Review of Weight Loss Drug Orlistat

2009-08-24T16:50:00.004-07:00

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical (orlistat 120 mg) and the over-the-counter medication Alli (orlistat 60 mg).

The drugs were approved for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury, including 6 with liver failure, in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

Reports outlining the adverse events were submitted to FDA’s Adverse Event Reporting System.The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time.

Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine.

Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA's MedWatch Adverse Event Reporting program

Further information regarding orlistat will be released by the FDA as soon as its review of complete.

Orlistat is manufactured by Swiss pharmaceutical firm Roche. The drug is marketed as Alli by British drugmaker GlaxoSmithKline PLC and sold as Xenical by Roche. The FDA first approved Xenical in 1999 and alli in 2007. Glaxo reported $123 million in sales for Alli in 2008, while Roche posted $472 million in revenue for Xenical.

Dietary Supplement and Protein Powder Manufacturers Companies Failed to Declare Allergens in Products

2009-07-10T14:09:00.005-07:00

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

Undeclared Ingredients

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

Failing to correct filthy conditions

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Weight Loss in Overweight and Obese Women Reduces Urinary Incontinence

2009-01-29T10:30:00.008-07:00

Reducing urinary incontinence can now be added to the extensive list of health benefits of weight loss, according to a clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Women’s Health (ORWH), both part of the National Institutes of Health (NIH). The paper reporting the results of the trial will be published in the January 29 issue of the New England Journal of Medicine.

The Program to Reduce Incontinence by Diet and Exercise (PRIDE), conducted in Birmingham, Alabama, and Providence, Rhode Island, recruited a total of 338 obese and overweight women who leaked urine at least 10 times per week. The women were randomly assigned to either an intensive six-month weight-loss program of diet, exercise and behavior modification (226 women) or to a group that received information about diet and exercise, but no training to help them change habits (112 women).

The investigators report that women in the intensive weight-loss group lost an average 8 percent of their body weight (about 17 pounds) and reduced weekly urinary incontinence episodes by nearly one-half (47 percent). In contrast, women in the information-only group lost an average 1.6 percent of body weight (about 3 pounds) and had 28 percent fewer episodes.
'Clearly, weight loss can have a significant, positive impact on urinary incontinence, a finding that may help motivate weight loss, which has additional health benefits such as preventing type 2 diabetes,' said NIDDK Director Griffin P. Rodgers, M.D.

Urinary incontinence affects more than 13 million women in the United States and accounts for an estimated $20 billion in annual health care costs, according to the paper. Obesity is an established and modifiable risk factor for urinary incontinence, but conclusive evidence for a beneficial effect of weight loss on urinary incontinence has been lacking. The PRIDE trial provides evidence supporting weight loss as a treatment for incontinence.

An important finding of the study is the difference between the two groups in the reduction of incontinence. Among women in the weight-loss group, 41 percent achieved a clinically relevant reduction of at least 70 percent of total incontinence episodes per week, whereas 22 percent of women in the information-only group achieved the same level of reduction.

At six months, women in the weight-loss group were significantly more satisfied with the change in their incontinence than were women in the information-only group. This was assessed through self-reported perceived change in frequency of incontinence, volume of urine loss, the degree to which incontinence was a problem, and satisfaction with the change in incontinence.

'Studies have documented that behavioral interventions help people lose weight, which helps decrease the risk of developing type 2 diabetes and high blood pressure, improve control of high blood pressure and cholesterol levels, and enhance mood and quality of life,' explained Leslee L. Subak, M.D., of the University of California, San Francisco (UCSF) and lead author of the study. 'Our results suggest that a decrease in urinary incontinence is another health benefit associated with weight loss and that weight reduction can be a first-line treatment in overweight and obese women.'

Results from previous studies suggest that a weight loss of 5% to 10% has an efficacy similar to that of other nonsurgical treatments and should be considered a first line therapy for incontinence.

Weight loss in PRIDE is comparable to that observed in the Diabetes Prevention Program (DPP) and in the ongoing Action for Health in Diabetes (Look AHEAD), two NIDDK-sponsored clinical trials in people with type 2 diabetes. The PRIDE intensive weight-loss program was modeled after these two trials.

In an interview, earlier today, the investigators noted that while the results of the study indicated that incontinence diminished in both groups, they believe that some of reduced incontinence in the 'information-only group' is based on adopting some of the additional techniques included in the educational materials.

Because weight loss and weight maintenance can be highly challenging for the individual patient, clinicians are encouraged to help their patients by identifing a number of appropriate local or online resources to which they can refer patients for additional support.

For more information:

Subak LL, Wing R, Smith West D, et al. Weight Loss to Treat Urinary Incontinence in Overweight and Obese Women. NEJM 360 (5):481-490, January 29, 2009.

Also read:

Program to Reduce Incontinence by Diet and Exercise (PRIDE) click here and type NCT00091988 in the search window;
Diabetes Prevention Program DPP and the Look AHEAD trials.
Incontinence in women

Also read PubMed abstracts:

Richter HE, Creasman JM, Myers DL, et al. Urodynamic characterization of obese women with urinary incontinence undergoing a weight loss program: the Program to Reduce Incontinence by Diet and Exercise (PRIDE) trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1653-1658. Epub 2008 Aug 5.
Subak LL, Whitcomb E, Shen H, et al. Weight loss: a novel and effective treatment for urinary incontinence. J Urol. 2005 Jul;174(1):190-5. Click here to contact the authors.
Subak LL, Brubaker L, Chai TC, et al. High costs of urinary incontinence among women electing surgery to treat stress incontinence. Obstet Gynecol. 2008 Apr;111(4):899-907.

More Americans Report Being Obese

2009-01-21T19:26:00.005-07:00

An estimated 25.6 percent of US adults reported being obese in 2007 compared to 23.9 percent in 2005, an increase of 1.7 percent. And this number is climbing. In three states, the prevalence of self-reported obesity among adults age 18 or older was above 30 percent. None of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal to reduce obesity prevalence to 15 percent or less.

The proportion of US adults who self-report they are obese increased nearly 2 percent between 2005 and 2007. An estimated 25.6 percent of US adults reported being obese in 2007 compared to 23.9 percent in 2005, an increase of 1.7 percent. The report also finds that none of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal to reduce obesity prevalence to 15 percent or less.

In three states - Alabama, Mississippi, and Tennessee - the prevalence of self-reported obesity among adults age 18 or older was above 30 percent. Colorado had the lowest obesity prevalence at 18.7 percent. Obesity is defined as a body mass index (BMI) of 30 or above. BMI is calculated using height and weight. For example, a 5-foot, 9-inch adult who weighs 203 pounds would have a BMI of 30, thus putting this person into the obese category.

The data were derived from CDC's Behavioural Risk Factor Surveillance System, a state-based telephone survey that collects information from adults aged 18 years and older. For this survey more than 350,000 adults are interviewed each year, making BRFSS the largest telephone health survey in the world. BMI was calculated based on this self-reported information.

'The epidemic of adult obesity continues to rise in the United States indicating that we need to step up our efforts at the national, state and local levels,' said Dr William Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity. 'We need to encourage people to eat more fruits and vegetables, engage in more physical activity and reduce the consumption of high calorie foods and sugar sweetened beverages in order to maintain a healthy weight.'

The study found that obesity is more prominent in the South, where 27 percent of respondents were classified as obese. The percentage of obese adults was 25.3 in the Midwest, 23.3 percent in the Northeast, and 22.1 percent in the West.

By age, the prevalence of obesity ranged from 19.1 percent for men and women aged 19-29 years to 31.7 and 30.2 percent, respectively, for men and women aged 50-59 years.

'Obesity is a major risk factor for a number of chronic diseases such as type 2 diabetes, heart disease and stroke. These diseases can be very costly for states and the country as a whole,' said Deb Galuska, associate director for science for CDC's Division of Nutrition, Physical Activity and Obesity.

For more information on how you can combat obesity, contact your doctor or visit the information site from the CDC.

New enzyme let mice to gorge without becoming obese, new study finds.

2009-01-13T09:18:00.015-07:00

Researchers at the University of California, Berkeley, California, have zeroed in on an enzyme that plays a key role regulating metabolism and weight in mice and say a drug that inhibits this target could do the same for people. The new enzyme plays a far more important role than expected in controlling the breakdown of fat. The findings of their study have been published in the January 11, 2009 edition of Nature Medicine. One of the remarkable findings reported by the researchers is that mice that have had this enzyme disabled remained lean despite eating a high-fat diet and losing a hormone that suppresses appetite.

'We have discovered a new enzyme within fat cells that is a key regulator of fat metabolism and body weight, making it a promising target in the search for a treatment for human obesity,' said Hei Sook Sul, UC Berkeley professor of nutritional sciences and toxicology and principal investigator of the research.

Sul's research team also includes the three co-lead authors of the paper, all from UC Berkeley's Department of Nutritional Sciences and Toxicology, Kathy Jaworski, former post-doctoral researcher, Maryam Ahmadian, graduate student, and Robin Duncan, post-doctoral fellow.

The enzyme in the spotlight, adipose-specific phospholipase A2 (AdPLA), is found in abundance only in fat tissue. AdPLA sets off a chain of events that increases levels of a signaling molecule called prostaglandin E2 (PGE2), which suppresses the breakdown of fat. Mice that have no AdPLA have lower PGE2 levels and a higher rate of fat metabolism.

'When levels of PGE2 are decreased because of the lack of AdPLA, fat breakdown proceeds unchecked, resulting in leanness even in animals that eat all day long,' said co-lead author Duncan.

In the study, mice that had the gene for AdPLA expression knocked out were compared with a control group of normal mice. As soon as the mice were weaned at about 3 weeks of age, researchers began offering the two groups of mice an all-you-can-eat buffet of tasty, high-fat foods.

Notably, the enzyme did not appear to affect appetite since the two groups ate equivalent amounts. However, as the mice aged, the disparity in weight gain became clear. By 64 weeks of age - considered the twilight years in a lab mouse's lifespan - the mice that lacked the AdPLA enzyme averaged only 39.1 grams, a weight more typical of a low-fat diet, while the control mice weighed in at a hefty 73.7 grams.

No reduction in fat cells
The researchers noted that the missing AdPLA did not change the number of fat cells, but simply kept the cells from accumulating excess fat. The researchers also studied whether loss of AdPLA could prevent genetic obesity in mice. They compared mice that lacked leptin, the hormone that signals when the body is full, with mice that lacked both AdPLA and leptin. Leptin-deficient mice are voracious eaters, typically consuming two to three times more food per day than normal mice, and they rapidly develop obesity.

Increase AdPLA
In this study, leptin-deficient mice ate an average of 5 grams of food per day, while mice that lacked both AdPLA and leptin ate 7.5 grams. Typically, normal mice will eat only 2-3 grams per day. By 17 weeks of age, the leptin-deficient mice were already hitting the scales at 75 grams. In comparison, mice that lacked both AdPLA and leptin weighed just under 35 grams.
The researchers found that levels of AdPLA increase after eating to block fat breakdown, and decrease with fasting to allow fat breakdown to proceed efficiently. They also found that levels of AdPLA are higher in obese mice.

'This means that local signals in fat tissue allow fat cells to directly regulate fuel provision for the body, which changes our fundamental understanding of how the body regulates fat breakdown,' said Ahmadian, another study co-lead author. 'We found that mice deficient in AdPLA expend more energy than normal mice, and they also burn more fat directly within fat cells.'

Before this paper, the assumption had been that the major players in controlling fat metabolism and body weight were endocrine factors, primarily hormones that are secreted by different organs and glands and travel through the bloodstream to fat tissue, the authors said.

The new findings show that a large portion of the action is occurring within the actual fat tissue, mainly through the autocrine and paracrine action of PGE2 that acts locally within a cell or small group of cells.

How research translates
The researchers caution that previous discoveries in fat metabolism and appetite regulation have not always translated well from mice to humans. Although some people have mutations in the gene that codes for AdPLA, it remains to be seen what effect these mutations have in humans, they said.

They also noted that inhibiting the expression of AdPLA in mice led to greater insulin resistance and a four-fold increase in fat content in the liver. However, tests of liver function were largely normal.

Nevertheless, AdPLA may become an attractive target in developing a treatment to combat obesity, the researchers said. If excess fat can be burned before it escapes the fat cell, it can never get into the bloodstream to negatively affect other organs, such as the heart.

'We believe that the effects in the liver are due to the extremely high rate of fat breakdown and drastic leanness in these mice, so we are looking to see if reducing rather than completely eliminating AdPLA can provide effective protection against obesity without secondary effects,' said Duncan.

For aditional information:

Jaworski K, Ahmadian M, Duncan RE, et al. AdPLA ablation increases lipolysis and prevents obesity induced by high-fat feeding or leptin deficiency. Nat Med. 2009 Jan 11. [Epub ahead of print] Full text article. Contact the authors.

Also read PubMed abstracts:

Duncan RE, Sarkadi-Nagy E, Jaworski K, et al. Identification and Functional Characterization of Adipose-specific Phospholipase A2 (AdPLA). J Biol Chem. 2008 Sep 12;283(37):25428-36. Epub 2008 Jul 9

Tainted Weight Loss Pills Put Consumers’ Health at Risk

2008-12-23T16:04:00.008-07:00

Earlier this week, the U.S. Food and Drug Administration (FDA) alerted consumers in North America not to purchase or consume one of more than 25 different products marketed for 'weight loss' because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk and lead to such health problems as high blood pressure, seizures, heart attack, or stroke.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products, often marketed as ‘dietary’or ‘food supplements,’ include sibutramine (a controlled substance, manufactured and legally distributed by Abbott Laboratories as Meridia in the U.S. and Canada, and Reductil in Europe and most other countries), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels.

Prescription drugs vs. supplements
The Dietary Supplement Health and Education Act, commonly known as DSHEA, does not qualify dietary or food supplements as ‘drugs’ As a result, many of these products fall outside the realm of the FDA regulations for (prescription) drugs. While pharmaceutical companies must meet rigorous conditions for manufacturing, packaging, labeling, advertising and distribution of prescription drugs, dietary and food supplements do not require any proof. However, supplement labels are supposed to exactly state what’s in the product. Unfortunately, as this FDA analysis shows, this is not always the case.

While prescription drugs are monitored by the FDA, the agency does not monitor ‘dietary’or ‘food supplements’ as they do prescription drugs. In this case however, the FDA warned against the use of supplements contaminated with a variety of unlisted pharmaceuticals. Some of these active pharmaceutical ingredients may be approved for marketing as prescription drugs in the United States or Europe. However, the fact that these products are not listed as ingredients on the supplement product labels, as required by law, or exceeds recommended dosage levels, is a violation of existing regulations and a major concern to medical authorities. Dr Robert Mayr, an internationally recognized expert on dietary supplements, noted that: ‘There is a real danger that these ‘weight loss pills’ are putting consumers' health at risk.’

These weight loss products are often promoted and sold on web sites and in some retail stores. Some of the products claim to be ‘natural’ or to contain only ‘herbal’ ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. Therefor, these products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their health care professional immediately. The FDA encourages consumers to seek guidance from a health care professional before purchasing weight loss products.

‘These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,’ said Dr Janet Woodcock, MD., director, Center for Drug Evaluation and Research, FDA. ‘Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.’

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA's inspections and the companies' inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

In October 2008 the European Medicines Agency (EMEA) completed a review of rimonabant following concerns over the medicine’s psychiatric safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of rimonabant no longer outweigh its risks, and that its marketing authorisation should be suspended across the European Union (EU). Following these conclusions, Sanofi-Aventis, in November 2008, decided to discontinue the ongoing rimonabant clinical development program in all indications.

When in doubt...
Consumers in doubt about any ‘weight loss’ or dietary supplement they are currently using, should make sure to contact the manufacturer or distributor listed on the label. In all cases, health care professionals and consumers should report serious adverse events or side effects and product quality problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

The tainted weight loss products include the following products and brands:

Fatloss Slimming
2 Day Diet
3x Slimming Power
Japan Lingzhi 24 Hours Diet
5x Imelda Perfect Slimming
3 Day Diet
7 Day Herbal Slim
8 Factor Diet
7 Diet Day/Night Formula
999 Fitness Essence
Extrim Plus
GMP
Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules
Perfect Slim
Perfect Slim 5x
Phyto Shape
ProSlim Plus
Royal Slimming Formula
Slim 3 in 1
Slim Express 360
Slimtech
Somotrim
Superslim
TripleSlim
Zhen de Shou
Venom Hyperdrive 3.0

A delicious new, low-carb, low-calorie and sugar-free energy drink hits the market.

2008-12-03T12:02:00.005-07:00

Having trouble getting started in the morning? Need more energy? At Vitaelin Nutraceuticals , a distributor of the top-quality weight management line BioLean® System and highly-concentrated Omega-3 supplement WINOmeg3complex™, we’re thrilled to meet the demands of the busy, overworked and tired by launching our new, low-calorie, low-carb and sugar-free Winrgy®, a revolutionary new energy and mental performance drink. The new sugar-free Winrgy® is an ideal energizer during stressful activities, while traveling long distances, or anytime peak performance is needed. This new energy drink delivers instant, long-lasting energy and mental performance without the crash or jitters.

Through nutrients in the diet, nerves are able to send signals throughout the body called neurotransmitters. One such neurotransmitter, noradrenaline, provides individuals with the necessary alertness and energy required in day-to-day activity. A unique blend of vitamins and minerals important to the creation of noradrenaline has been incorporated into new sugar-free Winrgy®, making it a delicious, invigorating, citrus-flavored energy drink, a nutritional alternative to coffee, cola and other soft-drinks.

Along with caffeine, vitamin C, vitamin B6, vitamin E, thiamin riboflavin, niacin and folate (as folic acid), new sugar-free Winrgy® contains taurine (2-aminoethanesulfonic acid), which is an essential amino acid found in many of the body's organs to aid digestion.

B-vitamins
Studies reveal that vitamin B2 (riboflavin) helps the body release energy from protein, carbohydrates and fat, while vitamin B12 (cobalamin) is given to combat fatigue and alleviate neurological problems, including weakness and memory loss. Another important component of new sugar-free Winrgy®, vitamin B3 (niacin), works with both thiamin and riboflavin in the metabolism of carbohydrates and is essential for providing energy for cell tissue growth. Niacin has also proven to dilate blood vessels and thereby increase blood flow to various organs of the body, sometimes resulting in a blush of the skin and a healthy sense of warmth. Unlike caffeine, new sugar-free Winrgy® offers all the raw materials necessary to continue the production of noradrenaline and is ideal for anytime performance is required.

A growing market
New Sugar-free Winrgy® is an instant gratification drink that gives consumers mental clarity and lasting stamina without the jitters or crash. Today’s busy lifestyle has recently driven the energy drink market to incredible, explosive growth. Since 2000, sales volume for energy drinks have increased by an impressive 75 percent and increased in value by 71 percent, with sales reaching $6.1 billion in 2005 alone. In addition, the combined sports food and drink market grew an impressive 48 percent between 2000 and 2005, making it one of the highest growth rates among all food and beverage categories.

The demands of professional athletes to weekend warriors require high levels of energy, and Winrgy® delivers an energetic, competitive edge along with mental focus. After two hours of participating in sports or working out, muscle glycogen is depleted and fatigue can set in, leading to reduced recovery, poor quality training and chronic fatigue. Winrgy® can instantly increase glycogen levels and maintain energy levels of athletes for four to six hours. Athletes can also hydrate with Winrgy® to help avoid dehydration, which can lead to reduced mental function and performance, poor decision making, anticipation and skill delivery. An ideal energizer during demanding activities, Winrgy® helps maintain energy and mental fitness with choline and powerful B vitamins, both of which are essential in the production of the acetylcholine, the most abundant neurotransmitter in the body. Acetylcholine promotes concentration, good memory and healthy sleep patterns.

New sugar-free Winrgy® is the perfect vitamin and mineral supplement for people with active lifestyles as its essential ingredients help the body convert energy from carbohydrates, protein and fat. Unlike most canned energy drinks, new sugar-free Winrgy® comes in easy-to-use packets, a perfect fit in pockets and purses for on the spot get-up-and-go.

Part of the Physicians’ Health & Diet® Program, consumers say that the new sugar-free Winrgy® tastes great! Since it’s sweetened with Xylitol, it’s both healthier and better tasting than all the other sugar-free energy drinks available.

To see the new sugar-free Winrgy® video-advertisement, click here.

Read more: How does new, sugar-free, Winrgy® compare? Click here for more information.

New guidelines recommend increasing vitamin D intake

2008-12-02T12:19:00.005-07:00

Inadequate exposure to sunlight predisposes to vitamin D deficiency. This may lead may result in impaired bone mineralization which may lead to a disease known as rickets in children and osteomalacia in adults. It may even contribute to osteoporosis.

Vitamin D deficiency may also result from inadequate intake, reduced absorption, impaired or abnormal metabolism or resistance to the effects of vitamin D.

Deficiency of vitamin D is preventable with adequate nutritional intake with nutritional and dietary supplements or by exposure to sunlight. Unfortunately, both dietary intake of vitamin D (other than with supplements) and exposure to sunlight continue decline. Research shows that this especially noticeable with exclusively breastfed infants and infants with darker skin pigmentation in the United States and other Western countries.

Based on recent research The American Academy of Pediatrics (141 Northwest Point Blvd, Elk Grove Village, IL 60007, phone 847 434 4000, http://aap.org) is doubling the amount of vitamin D it recommends for infants, children and adolescents. The new clinical report, "Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents," recommends all children receive 400 IU a day of vitamin D, beginning in the first few days of life. The previous recommendation, issued in 2003, called for 200 IU per day beginning in the first two months of life.

The change in recommendation comes after reviewing new clinical trials on vitamin D and the historical precedence of safely giving 400 IU per day to the pediatric population. Clinical data show that 400 units of vitamin D a day will not only prevent rickets, but treat it. This bone-softening disease is preventable with adequate vitamin D, but dietary sources of vitamin D are limited, and it is difficult to determine a safe amount of sunlight exposure to synthesize vitamin D in a given individual. Rickets continues to be reported in the United States in infants and adolescents. The greatest risk for rickets is in exclusively breastfed infants who are not supplemented with 400 IU of vitamin D a day.

Adequate vitamin D throughout childhood may reduce the risk of osteoporosis. In adults, new evidence suggests that vitamin D plays a role in the immune system and may help prevent infections, autoimmune diseases, cancer and diabetes.

"We are doubling the recommended amount of vitamin D children need each day because evidence has shown this could have life-long health benefits," said Frank Greer, MD, FAAP, chair of The American Academy of Pediatrics (AAP) Committee on Nutrition and co-author of the report. “Supplementation is important because most children will not get enough vitamin D through diet alone.”

"Breastfeeding is the best source of nutrition for infants. However, because of vitamin D deficiencies in the maternal diet, which affect the vitamin D in a mother’s milk, it is important that breastfed infants receive supplements of vitamin D,” said Carol Wagner, MD, FAAP, member of the AAP Section on Breastfeeding Executive Committee and co-author of the report. “Until it is determined what the vitamin D requirements of the lactating mother-infant dyad are, we must ensure that the breastfeeding infant receives an adequate supply of vitamin D through a supplement of 400 IU per day.”

The new recommendations include:

Breastfed and partially breastfed infants should be supplemented with 400 IU a day of vitamin D beginning in the first few days of life
All non-breastfed infants, as well as older children, who are consuming less than one quart per day of vitamin D-fortified formula or milk, should receive a vitamin D supplement of 400 IU a day
Adolescents who do not obtain 400 IU of vitamin D per day through foods should receive a supplement containing that amount
Children with increased risk of vitamin D deficiency, such as those taking certain medications, may need higher doses of vitamin D
Given the growing evidence that adequate vitamin D status during pregnancy is important for fetal development, the AAP also recommends that providers who care for pregnant women consider measuring vitamin D levels in this population.

For a copy of the report, visit the website of the AAP at http://www.aap.org/new/VitaminDreport.pdf

For more information about Vitamin D, click here.

Functional and energy drinks: a brief history

2008-12-01T11:19:00.006-07:00

Market studies are showing that the demand for ‘functional’ energy drinks continues to growing! This expanding market trend is timed perfectly with the release of the new sugar-free Winrgy®, a new energy drink loaded with vitamins, minerals and amino acids. This low-calorie, low-carb drink delivers instant, long-lasting energy and mental performance without the crash or jitters.

Winrgy®, distributed by Vitaelin Nutraceuticals (4960 South Gilbert Rd, Suite 1-286, Chandler, Arizona, USA +1 480 626 7218), is the answer to growing consumer demand for more natural energy drinks and is geared toward an 18-35 year-old demographic. Along with caffeine, vitamin C, B6, vitamin E , thiamin riboflavin, niacin and folate (as folic acid), the functional energy drink contains taurine (2-aminoethanesulfonic acid), which is an essential amino acid found in many of the body's organs to aid digestion.

A growing trend
While other drink segments, such as bottled water and carbonated or ‘fizzy’ soft-drinks are fatigued and showing saturation or even decline, the market for ‘functional’ and ‘energy’ drinks is not affected and rapidly growing. Data compiled by Zenith International Ltd (7 Kingsmead Square, Bath BA1 2AB United Kingdom, phone +44 (0)1225 327900), a European drinks consultancy based in England, shows a market valued at €3.76 billion ($ 5.4 billion) in 2007, with growth at 11 per cent over 2006 for a total of 487 million litres. Although consumer spending is down in most western lands, analyst at Zenith expect that sales of ‘functional’ and ‘energy’ drinks will grow approximately 8% for the next five years, approaching a total volume of nearly 700 million litres by 2012. The prognoses is supported by Mintel International Group Ltd (18-19 Long Lane, London EC1A 9PL, United Kingdom, phone +44 (0)20 7606 4533), a privately owned market research firm, which predicts this continued growth to reach €6.97 billion ($10 billion) of total sales by 2010.

Today’s most national markets for ‘energy’ drinks are dominated by Red Bull, (Red Bull GmbH, Am Brunnen 1, A-5330, Fuschl am See, Austria, phone +43 662 6582 0) which is sold in more than 140 countries in the world and holds about 60% of the total market of energy drinks. While analysts predict an increase in completion, they don’t expect to see a major shift in brand loyalty or market domination.

Traditional soft-drinks manufacturers are turning to 'added functional ingredients' as a means of enlivening the sometimes tired appearance of their mainstream soft-drinks. As Goliaths they are looking to the Davids of the industry, the smaller, emerging, soft-drinks manufacturers who already have embraced an array of ‘functional’ and ‘energy’ options in order to differentiate their products. More than ever, with health and wellness being the driving factor, ‘functional’ and ‘energy’ drinks are entering a new, uncharted, area.

What are ‘functional’ drinks?
To date, there is no real, universally accepted, definition of the term ‘functional’ drinks. However, the generally held idea is that ‘functional’ drinks are beverages fortified with a hodgepodge of nutritional and dietary supplements such as vitamins and minerals, mild stimulants such caffeine, antioxidants, amino acids, and herbal extracts like gingseng, ginko biloba, guarana, yerba mate, green tea polyphenols, kola nut extract and other ingredients and that they may offer specific health promoting benefits and/or disease preventing properties over and above the usual nutritional value. Products within this category are given a number of names including sports-drinks, isotonic-drinks, hypotonic-drinks, energy-drinks, functional-drinks, stimulant- or power-drinks, tonics or elixirs.

But the first ‘functional’ drinks did not resemble the soft-drinks we associate today with ‘functional’ drinks. In the early 1930s Dr Minoru Shirota, then working in the microbiology lab at Kyoto Imperial University's School of Medicine (Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501, Japan, phone +81 75 753 2047), succeeded in culturing and utilizing lactic acid bacteria. Based on this culture, Shirota started the production of his yogurt-like probiotic-drink containing Lactobacillus casei strain shirota which he marketed under the brand name Yakult (today produced and marketed by Yakult Honsha Co., Ltd., 1-19 Higashi Shimbashi 1-chome, Minato-ku, Tokyo, Japan, phone +81 33 574 8960).

Since then, over a dozen brands of ‘functional’ drinks containing calcium, iron, amino acids, b-carotene, fiber, hangover cures, energy boosters or ingredients to help joint flexibility, have been developed by carefully marrying health and medicine. From the 1930 onwards, many drinks and foodstuffs around the world were fortified with Vitamin D until health authorities in the 1950s limited Vitamin D fortification to milk and read-made breakfast cereals alone, only to allow Vitamin D fortification of a broader range of products again in the late 1980s.

Anti flu beverages
Due to the fact that the potency of vitamins erodes over time, ‘functional’ drinks generally have a relatively short shelf life. To combat these effects Degussa FreshTech Beverages LLC (735 N Water St Suite 1128, Milwaukee, WI 53202-4105, Phone +1 262 549 2517) and Ball Packaging Europe GmbH (formerly Schmalbach-Lubeca, Kaiserswertherstraße 115, Ratingen, D-40880, Germany, phone: +49 2102 130 0) jointly developed the ground-breaking ‘FreshCan®’ technology. This new technology enables vitamins, minerals or probiotic additives to be stored in a dry state inside a can until the consumer opens it. Today, New York based Brain-Twist Inc. (535 W 34th Street, New York, NY 10001-1303, phone +1 212-594-6772) offers this new technology for their immune boosting beverage Defense Effervescent Supplement or ‘Defense’, a beverage specifically designed to combat flu season.535 W 34th St, New York, NY 10001-1303 535 W 34th St, New York, NY 10001-1303 So far, the drink is only available in 7-Eleven stores (2065 Sidewinder Dr, Park City, UT 84060, phone +1 435 645 9595) in North America.

How did we get here?
The history of ‘functional’ and ‘energy’ drinks is quite interesting. Although not marketed as such, the granddaddy of today’s ‘energy’ drinks is probably Irn-Bru, first produced by A.G Barr Plc. (Westfield House, 4 Mollins Road, Westfield, Cumbernauld, North Lanarkshire, G68 9HD, Scottland, phone +44 (0)1236 852400) in 1901, under the name Strachan's brew and later (1946) changed in Irn-Bru because the drink was not really brewed.

Another early brand of ‘energy’ drink can be found in England. Lucozade produced by pharmaceutical giant GlaxoSmithKline Plc. (980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom, phone +44 20 8047 5000) was first developed in 1927 by a Newscastle Chemist searching for a source of energy for the ‘sick and infirm’. After several years of experimenting, Glucozade, a glucose syrup containing drink, was introduced as a special drink for ‘aiding the recovery’ and only available in hospitals. In 1929 the name was changed to the more recognizable ‘Lucozade’. Later, when popularity grew, it also became available outside hospitals and today it is one of the strongest brands sold in England.

While select number of energy stimulating drinks were developed and marketed around the world in the early part of the 20th century, the real advent of ‘energy’ drinks started in Japan were the most popular energy drinks date back to the late 1950s and early 1960s. Before crossing over to the ‘west’ energy drinks had been enthusiastically consumed in Japan and other Asian countries for many decades. Most of the then popular original energy drinks bear little resemblance to modern soft drinks as they were generally sold in small brown glass medicine bottles by pharmacies. Called ‘genki drinks’, these drinks were primarily marketed to the hard working ‘salarymen,’ the overworked and underpaid office clerks for which Japan is famous.

Among the first companies to enter the energy drinks market was Taisho Pharmaceuticals Co., Ltd. (24-1, Takada 3-chome, Toshima-ku, Tokyo 170-8633, Japan, Phone +81 3 3985 1111). In 1962 Taisho developed its drink concept by combining taurine with vitamin B to create Lipovitan D. Today, this brand is with almost a 60% share, still dominating the domestic Japanese market, closely followed by Oronamin C, a carbonated ‘fizzy’ health drink containing isoleucine and other essential amino acids as well as vitamin B2, B6 and C, produced by Otsuka Pharmaceutical Company Ltd. (2-16-4 Konan, Minato-ku, Tokyo 108-8242, Phone: +81-3-6717-1400). More recently Taisho developed special low-calorie versions for women and vitamin-fortified energy drinks for children.

The Asian ‘energy’ drinks remained quite unknown in the western world until Jolt Cola, made by The Jolt Cola Company, now Wet Planet Beverages (Rochester, New York 14625 USA, Phone +1 585 381 3560), was introduced in the United States in 1985. This high caffeinated cola drink was developed by C.J. Rapp, a beverage inventor, and marketed with the initial slogan ‘All the sugar and twice the caffeine’ to promote vigilance and wakefulness.

In Europe, the concept of energy drinks was pioneered by the Austrian company of S. Spitz GmbH., (Fiedlerstraße 10, POB 102, A-4041 Linz, +43/732/70 97-0, a privately held company engaged in manufacturing non alcoholic drinks, syrups, liqueurs, schnapps, brandy, special spirits, ketchup, mustard, mayonnaise, wafers and rolls) when the company introduced Power Horse), a revitalizing energy drink designed to increases mental and physical power, in the spring of 1994.

But today’s dominating energy drink, Red Bull, was developed just a few years earlier, in 1987, when Austrian entrepreneur Dietrich Mateschitz and his Thai business partners Chaleo and Chalerm Yoovidhya founded Red Bull GmbH and created the ghastly tasting berry-flavored energy drink, marketing it to young people using cheeky advertising and extreme sports sponsorships. Spiked with taurine and glucuronolactone the 8.3-ounce can contained 80 milligrams of caffeine, more than double the dose found in an 12-ounce can of regular Coca-Cola (40 mg/330 ml can), but with less calories per serving (110 vs. 140). The high concentration of caffeine (similar to that found in an average cup of brewed coffee, typically 100 mg/250 ml cup, but 72 mg for a U.S. regular 6 fluid ounces cup of coffee), glucose, sucrose, taurine and glucuronolactone was supposed to increase metabolism, thereby improving the drinkers’ concentration, energy, and endurance.

Red Bull’s Asian Origin
Mateschitz and his partners based their drink on the Krating Daeng, a very sweet, non- carbonated syrupy tonic produced by T.C. Pharmaceuticals Industries Company Ltd (39/13 Moo 8 Ekachai Rd., Bangkok, 10150, Thailand, +66 02 415 2258) and sold in pharmacies in Thailand as a revitalizing agent. Interestingly enough, Krating Daeng itself was based on the Japanese ‘energy drink’ Lipovitan D.

Red Bull was an instant hit in Austria and sales continued to rapidly grow. Marketed as ‘to combat mental and physical fatigue’, Red Bull was soon launched in other European countries. Initially, the drink was banned in France and Denmark because of health concerns over the high caffeine level and the use taurine. Today, Red Bull with its enticing brand motto ‘Red Bull vitalizes the body and mind’ has taken almost half of the US market for energy drinks and up to 80% in some other western countries.

To combat the critique for the negative effects of taurine, Red Bull replaced it with arginine in France. Arginine is a semi-essential amino acid linked to enhanced immunity, the release of the Human Growth Hormone (HGH), greater muscle mass, rapid wound healing, increased sexual potency, and helping to reverse atherosclerosis.

David vs. Goliath
Major beverage companies, including PepsiCo, Coca-Cola and MillerCoors, have tried to duplicate the success of Red Bull, Power Horse, Jolt Cola and other energy drinks developed by smaller and more innovative companies. These attempts did not always succeed.

For example, In 1995 PepsiCo Inc.(700 Anderson Hill Road Purchase, NY 10577, USA, phone +1 914 253-2000) launched Josta, a ‘high-energy drink’ with guaraná and caffeine and a predominately fruity flavor and a hint of spice. After a flawed market introduction and a change in corporate strategy, PepsiCo discontinued the drink in 1999. Today, PepsiCo owns not only the established Mountain Dew brand, but also a variety of brands, including the AMP energy drinks, dubbed as Pepsi's first real entry into the energy drink market, that taste like Mountain Dew with a bit more bite, and Jeff Gordon 24 Energy, a brand new energy drink uniquely formulated for race fans and energy drinkers.

MillerCoors (MillerCoors LLC, 3939 West Highland Boulevard, Milwaukee, WI 53208, USA), a joint venture between SABMiller Plc. (One Stanhope Gate, London W1K 1AF, England, phone +44 20 7659 0100) and Molson Coors Brewing Company(1225 17th Street, Suite 3200, Denver, CO 80136, USA, Phone +1 303-277-3500), which owns Sparks, a caffeinated alcohol beverage with a blend of caffeine, taurine, guarana and ginseng extract, has made number of questionable decisions and downright marketing blunders with their alcohol/energy hybrid concept. This has led to a massive backlash against the beverage and may industry observers believe that this may spell the end of the alcohol/energy concept drinks altogether.

Recently, the nonprofit Center for Science in the Public Interest(1875 Connecticut Ave. N.W., Suite 300, Washington, D.C. 20009, USA, Phone +1 202 332 9110) filed suit against MillerCoors Brewing Company because Sparks has more alcohol than regular beer and contains unapproved additives. The lawsuit is asking the Superior Court of the District of Columbia to stop the company from selling the controversial drink, which is also under scrutiny from state attorneys general. Sparks products contain 6 to 7 percent alcohol by volume, as opposed to regular beer, which typically has 4 or 5 percent alcohol. Also unlike beer, Sparks’ appeal to young people is enhanced by its sweet citrusy taste, redolent of SweeTarts candy, and the bright color of orange soda. (Sparks Light also contains the artificial sweetener sucralose). As a result of the suit, the planned release of Sparks Red, which will have 8 percent alcohol by volume, has been temporarily postponed.

Over the last two decades, soft-drink giant Coca-Cola (The Coca-Cola Company, 1 Coca-Cola Plaza, Atlanta, GA 30313-2499, USA, Phone +1 404 676 2121) has been developing its own line of ‘energy’ drinks with varying success. The company brands include, among others, Glacéau Vitaminenergy, Full Throttle, Rehab, Vault and TaB energy. However, it’s most famous and successful beverages outside the cola-drinks are ‘functional’ drinks marketed under the Minute Maid brand.

Minute Maid Heart Wise is the first orange juice containing natural sourced plant sterols and is clinically proven to help reduce cholesterol. The company also markets orange juice with calcium, and was the first to nationally launch orange juice with calcium plus vitamin D, low acid orange juice, orange juice with vitamins C and E plus Zinc. Its most controversial ‘functional’ drinks, co-marketed with Nestlé (Société des Produits Nestlé S.A., Avenue Nestlé 55, 1800 Vevey, Switzerland, Phone +41 21 924 2111), is no-doubt Enviga, a line of lightly sparkling green teas with EGCG and natural antioxidants designed to increase metabolism and help burn calories.

Déjà vu
The irony is that the innovative manufactures of today’s ‘functional’ and ‘energy’ drinks are positioning their products in the same way as the pioneering soft-drink companies in the late 19th and early 20th century by making all sorts of health claims. A good example is Coca-Cola). Invented by Atlanta, Georgia, based pharmacists Dr. John Pemberton, Coca Cola originally promoted their now infamous drink as ‘a valuable brain-tonic and cure for all nervous afflictions,’ and ‘offering the virtues of coca without the vice of alcohol.’ Later, until 1900 the drink was promoted as a tonic for good health (‘For headache and exhaustion, drink Coca-Cola’) and, after 1904, ‘Coca-Cola is a delightful, palatable, healthful beverage’. Health related claims were even used in recent years when the company called its product ‘a wholesome beverage’.

Another good example is Dr Pepper, manufactured by the Dr Pepper Snapple Group, Inc. (5301 Legacy Drive, Plano, TX 75024, USA Tel: +1 972 673-7000), which owns well-known brands such as Snapple, 7UP, Mott’s, A&W, Sunkist Soda, Hawaiian Punch, Canada Dry, Schweppes, RC Cola, Diet Rite, Squirt, Penafiel, Yoo-hoo, Rose’s, Clamato, Mr & Mrs T and many others.

Initially, Dr Pepper, the refreshing soft drink with the tart yet sweet flavor, was not marketed as a simple refreshment but as a health-drink. In the 1930s Dr Pepper’s famous slogan ‘Drink a bite to eat at 10, 2 and 4’ capitalized on the idea of an energy slump and that Dr. Pepper would provide the energy boost needed to make it through the day. Later, in the 1980s, Dr Pepper was marketed as ‘just what the Dr. ordered,’ while the diet version was advertised as ‘the taste you’ve been looking for.’

At the same time, 7 Up), the distinctive, tangy-fresh, lemon-lime flavored-drink, was marketed as a drink that ‘energizes… set you up, dispels brain cobwebs and muscular fatigue.’

By positioning their products as elixirs of good health, companies such as Red Bull, S. Sptiz, Hansen’s (Hansen Natural Corporation, 550 Monica Circle, Suite 201, Corona, CA 92880, USA and the maker of Monster Energy® brand energy drinks, Lost® Energy brand energy drinks, Joker Mad Energy(TM), Unbound® Energy and Ace Energy brand energy drinks, Rumba brand energy juice, and other manufacturers of ‘functional’ and ‘energy’ drinks are returning to the early days of soft-drink marketing, claiming all sorts of unverifiable health benefits.

‘Functional’ and ‘energy’ drinks are by their nature highly focused and targeted. To maintain their market value, it is imperative that soft-drink manufacturers respond to these pressures they face from competition, consumer demands and regulatory restrictions and continue to create and deliver choice for consumers while developing products that can offer consumers the opportunity to adopt a healthier lifestyle. At the same time, while borrowing from history, effective marketing, increased consumer acceptance as well as loyalty have been key contributors to the shift in consumer demands and the rapid growth of smaller, focused manufacturers.

It is in this complex and yet exciting industry that Winrgy®, the new invigorating citrus-flavored, low-carb energy-drink loaded with vitamins, minerals and amino acids, is the ‘new kid on the block’ and will satisfy the demand for a real energy drink!

Omega-3 fatty acids supplementations may help bipolar patients

2008-10-28T12:11:00.000-07:00

Bipolar disorder is a complex psychiatric disorder and is considered to be an important cause of worldwide disability. Mood stabilizers are the primary pharmacological intervention, both in the treatment of acute episodes and in prophylaxis.

There is, however, mounting evidence that dietary supplementation with omega-3 fatty acids may be beneficial in psychiatric conditions, particularly those involving disturbances of mood.

A recent review of almost 100 medical studies examining the current level of evidence regarding the efficacy of omega-3 fatty acid supplementation in improving bipolar disorder symptoms by researchers of the Columbia School of Nursing in New York, shows that omega-3 fatty acids in addition to prescribed medication, may benefit patients.

The reviewers identified seven relevant studies including 230 patients diagnosed with bipolar disorder who received, in addition to their prescribed medication, omega-3 fatty acid supplementation for between 4 and 52 weeks. Based on the outcome of these studies, they researchers concluded that supplementation was effective in more than half of the selected studies, demonstrating a statistically significant improvement in bipolar disorder symptoms.
The review conducted by Teresa Turnbull and colleagues and was published in the October 2008 issue of the Archives of Psychiatric Nursing (Arch Psychiatr Nurs 2008; 22: 305-311).

EPA and DHA
The researchers confirmed that patients using an omega-3 combination of eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA) demonstrated a statistically significant improvement in bipolar symptoms, whereas those using a single component of either EPA or DHA did not.

Benefit explained
The effects of omega-3 fatty acid supplementation can be explained by the fact that omega-3 fatty acids exert an inhibitory effect on the cell signaling pathway which is thought to be very similar to the mechanism of action of commonly prescribed mood stabilizers.

Patient adherence
Adherence to treatment can be a challenge for any patient diagnosed with a chronic disease requiring daily medication. This is not different for patients taking mood stabilizers. Side effects may often lead to patients discontinuing their medication, leading to inadequate medication.and treatment failures. ‘The question that researchers of omega-3 and bipolar disease are asking is whether supplementation with omega-3 can support the effect of prescription mood stabilizers in symptom reduction, which may, in turn, reduce dosing requirements, untoward side effects, and nonadherence,’ the researchers write in the October issue of Archives.

Improvement with omega-3 fatty acids
In reviewing the available data, the researchers identified that most patients diagnosed with bipolar disease continued their usual treatment, which included psychotropic medication, psychological therapy, or both. Overall, they reported that four of the seven studies showed a statistically significant improvement with omega-3 fatty acids supplementation in bipolar symptoms using screening tools and rating scales measure mental health symptoms. These scales include Young Mania Rating Scale, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and the Inventory of Depressive Symptomatology.

In conclusion, the researchers comment that ‘Due to its benign side effect profile and some evidence supporting its usefulness in bipolar illness, … omega-3 supplementation… may be a helpful adjunct in the treatment of selected patients.’

More study required
A different systematic Cochrane database review, studying the efficacy of omega-3 fatty acids as either a monotherapy or an adjunctive treatment for bipolar disorder by Montgomery and Richardson of the, Centre for Evidence-Based Intervention of the University of Oxford, also concluded that various studies confirm positive effects of omega-3 fatty acids as an adjunctive treatment for depressive but not manic symptoms in bipolar disorder.

But Montgomery and Richardson believe that these findings must be regarded with caution owing to the limited data available and that, in the treatment of bipolar disorder [the current results] are insufficient for us to draw definite conclusions that can guide clinical practice’.

In their conclusion, they confirm that although omega-3 fatty acids may be beneficial, there is an acute need for well-designed and executed randomized controlled trials.

For more information about Omega-3 fatty acids, visit Vitaelin Nutraceuticals at http://vitaelinhealthcenter.com.

Sources

Turnbull T, Cullen-Drill M, Smaldone A. Efficacy of omega-3 fatty acid supplementation on improvement of bipolar symptoms: a systematic review. Arch Psychiatr Nurs. 2008 Oct;22(5):305-11.
Montgomery P, Richardson AJ. Omega-3 fatty acids for bipolar disorder. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005169.

Large clinical trial fails to show beneficial effects of statins in patients with Chronic Heart Failure.

2008-10-28T11:55:00.000-07:00

Statin should not be considered for patients with heart failure (HF) of non-ischemic etiology, because lipid (cholesterol) lowering drugs do not translate into any clinically meaningful benefit for patients with heart failure (HF).

This is one of the unexpected outcomes from a large scale Italian study (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico Heart Failure or GISSI-HF study) involving 6,975 patients with New York Heart Association (NYHA) class II-IV HF of any cause and with any left ventricular ejection fraction who were randomized to receive daily supplementation of omega-3 fatty acids 1 g (805-882 mg eicosapentaenoic acid and docosahexaenoic acid in the average ratio 1:1.2) or placebo. In addition, 4,574 patients of the same group were also randomized to receive Crestor, (rosuvastatin calcium, 10 mg daily, Astra Zeneca) or placebo.

Trial design
The GISSI-HF trial was designed to investigate the effects of omega-3 fatty acids and statin therapy on mortality and morbidity in patients with chronic heart failure (HF).

Trial results
The results of this trial were presented by dr Luigi Tavazzi of the Fondazione Policlinico San Matteo, Pavia in Italy during the European Society of Cardiology (ESC) Congress 2008 in Munich, Germany and simultaneously published in The Lancet (1, 2)

Based on the results of the GISSI-HF study, the investigators concluded that the prescription of Crestor, which is indicated to reduce elevated total cholesterol, LDL-C, ApoB, non-HDL-C and triglyceride levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia, or any statin to patients with heart failure (HF) of non-ischemic etiology should not be considered. The primary reason for their conclusion is that the use of the lipid (cholesterol-) lowering drugs does not translate into any clinically meaningful benefit for patients with heart failure (HF). The data showed that 29% of people taking Crestor died from any cause against 28% of those given a placebo.

In other words, patients given Crestor proved just as likely to die early or be admitted to hospital with cardiovascular problems as those on standard therapy alone. Therefore, the investigators concluded that physicians can confidently stop statins in patients already taking them if convinced of the drug's futility or if they are concerned over multiple drug use. On the other hand doctors may be reassured that they can safely use statins in this population.

This is the second clinical trial for heart failure in which Crestor failed, suggesting that statins don't improve survival in patients with the chronic heart condition.

CORONA-study
The conclusions this study confirm the results of another medical study, the CORONA- trial (Controlled Rosuvastatin Multinational Trial in HF), published in 2007 in the New England Journal of Medicine, which researched the effect of Crestor in older patients (averaging 73 years of age) with moderate to severe systolic heart failure of ischemic origin who had already received extensive treatment with other drugs for cardiovascular disease (4).

Although Crestor reduced LDL-C (low density-lipoprotein) and C-reactive protein (CRP), it had no significant effect on cardiovascular outcomes as measured by the primary endpoint composite of cardiovascular death, nonfatal myocardial infarct or stroke. The investigators in this study failed to find any benefit from statin treatment in this patient population and concluded that ‘statins as a class may not be efficacious in patients with ischemic left ventricular systolic dysfunction who are already receiving evidence-based therapy for heart failure (HF)’.

The CORONA-trial, presented and published in November 2007, included only patients with coronary heart disease, whereas just 40% of patients in GISSI-HF had ischemic HF. After considering the results of both trials, the investigators conclude that the cholesterol-lowering effects of statins do not reduce ischemic events in patients with heart failure and that the apparent pleiotropic effects of statins does not influence HF development (5).

The outcome of the CORONA-trial showed that treatment with Crestor had no significant effect on cardiovascular outcomes. However, it did significantly reduce the number of hospitalizations from cardiovascular causes and from heart failure (HR).

Commenting on the results of both trials, dr Gregg Fonarow of the of the Ahmanson-UCLA (University of California) Cardiomyopathy Center in Los Angeles, USA said that ‘these two well-conducted clinical trials establish that, although statin therapy lowers concentrations of LDL-C, is well tolerated and seems reasonably safe, it does not produce meaningful improvements in survival in patients with chronic heart failure.’(3)

Sources

GISSI-HF investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008; DOI: 10.1016/S0140-6736(08)61241-6. Available online at: http://www.thelancet.com.
GISSI-HF investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008; DOI: 10.1016/S0140-6736(08)61241-6. Available online at: http://www.thelancet.com.
Fonarow GC. Statins and n-3 fatty acid supplementation in heart failure. Lancet 2008; DOI: 10.1016/S0140-6736(08)61239-8. Available online at: http://www.thelancet.com.
Kjekhus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007; DOI: 10.1056.nejmoa0706201. Available online at: http://www.nejm.org
Hjalmarson Å Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA)-Results of an outcomes trial in patients with ischemic heart disease and heart failure. American Heart Association 2007 Scientific Sessions; November 5, 2007; Orlando, FL, Late-breaking clinical trials 2.

Large clinical trial shows benefits of Omega-3 in patients with Chronic Heart Failure

2008-10-28T11:32:00.000-07:00

Good news: taking daily omega-3 fatty acids supplements (n-3 polyunsaturated fatty acids or PUFAs) may improve survival prospects and reduce mortality among patients with chronic heart failure (HF).

This is one of the unexpected outcomes from a large scale Italian study (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico Heart Failure or GISSI-HF study) involving 6,975 patients with New York Heart Association (NYHA) class II-IV HF of any cause and with any left ventricular ejection fraction who were randomized to receive daily supplementation of omega-3 fatty acids 1 g (805-882 mg eicosapentaenoic acid and docosahexaenoic acid in the average ratio 1:1.2) or placebo. In addition, 4,574 patients of the same group were also randomized to receive Crestor, (rosuvastatin calcium, 10 mg daily, Astra Zeneca) or placebo.

Trial design
The GISSI-HF trial was designed to investigate the effects of omega-3 fatty acids and statin therapy on mortality and morbidity in patients with chronic heart failure (HF).

Trial results
The results of this trial, boosting the health-giving reputation of omega-3 fatty acids fish oil supplementation, were presented by dr Luigi Tavazzi of the Fondazione Policlinico San Matteo, Pavia in Italy, during the European Society of Cardiology (ESC) Congress 2008 in Munich, Germany and simultaneously published in The Lancet (1,2).

The investigators conducting the trial were especially glad to report positive results for patients with chronic heart failure (HF), an exceptionally difficult to treat condition in which the heart struggles to pump blood effectively, which causes shortness of breath and other serious problems. They found that supplementation with omega-3 fatty acids greatly benefitted this group of patients.

Patients were followed for almost four years (average 3.9 years). The supplementation with omega-3 fatty acids resulted in a 1.8% absolute risk reduction, which translated into a 9% reduction of mortality. The results also show a 2.3% absolute reduction in all-cause death or hospital admission for cardiovascular reasons, which translated in an 8% reduction of admission to the hospital for cardiovascular causes.

‘Real world meaning’
Translating these percentages to ‘real world meaning’, the chairperson of the GISSI-HF steering committee, dr. Tavazzi, explained that the absolute risk reductions achieved with omega-3 means that 56 patients would need to be treated over a 4-year period to prevent one death, while 44 would need to be treated to avoid a death or a hospital admission for cardiovascular causes.

In his conclusion he said that ‘Although this moderate benefit was smaller than expected, we should note that it was obtained in a population already treated with various recommended therapies, was consistent across all the predefined subgroups, and was further supported by the findings of the per-protocol analysis.’

Benefits after 2 year
An interesting aspect of the study is that the benefits of supplementation with omega-3 fatty acids only became clear after about 2 years of treatment. Commenting on this remarkable aspect, dr Michel Komajda of the Pitie Salpetriere Hospital and the Université Pierre et Marie Curie, in Paris, France, one of the other investigators in this trial, explained that ‘Mortality curves for treated and placebo groups only started to diverge after two years of follow-up’.

He further explained that while current European and U.S. treatment guidelines focus on the role of omega-3 in preventing heart disease wider guidance to include treating heart failure could be warranted.’ The benefit was statistically significant and at present physicians have little further to offer patients with heart failure. Therefore, I am sure that those of us who have responsibility for drawing up the next CHF guidelines will pay a lot of attention to the results of this trial.’

This sentiment was echoed by dr Gregg Fonarow of the of the Ahmanson-UCLA (University of California) Cardiomyopathy Center in Los Angeles, USA. In an editorial in The Lancet (3) dr Fonarow stated that despite the fact that ‘many questions remain about the mechanism of action, optimum dosing, and formulation, supplementation with n-3 polyunsaturated fatty acids (omega-3 fatty acids) should join the short list of evidence-based life-prolonging therapies for heart failure (HF).’

Clear benefits of omega-3 fatty acids
Omega-3 fatty acids have in the past been linked to a range of health benefits, including reducing the risk of heart attacks, strokes, Alzheimer's disease and depression. One explanation is that omega-3 fatty acids are thought to help by stabilizing the electrical signals of the heart, as well as reducing blood fat levels. Furthermore, researchers believe that omega-3 fatty acids could possibly exert favorable effects on inflammatory processes, such as reductions in endothelial activation and cytokine production, as well as influence platelet aggregation, blood pressure, heart rate, ventricular function, and autonomic tone.

The advantage of omega-3 fatty acids supplementation is that it is cheap, well-tolerated and does not interfere with other medications, making it an attractive option for patients with chronic heart failure (HF) even if the clinical benefits are relatively moderate. This advantage was confirmed by dr Tavazzi who spoke of an ‘Effective, safe, simple, and cheap’ treatment option.

Long term effects
The GISSI-HF study showed that long term treatment with low-dose omega-3 fatty acids was associated with a significant reduction of total mortality of 21% in patients who survived a recent myocardial infarct (starting treatment within 3 months from symptom onset). The analysis of the causes of death showed that, among all cardiac causes, the most affected by omega-3 fatty acids was sudden cardiac death. Other experimental, epidemiological, as well as small size human studies confirm these findings and support the hypothesis that omega-3fatty acids can exert antiarrhythmic or antifibrillatory effects.This conclusion can be relevant for heart failure patients because nearly half of the deaths of patients with chronic heart failure (HR) are classified as sudden cardiac deaths. Analysis of the trial data showed that in patients with left ventricular dysfunction or heart failure enrolled in the trial, the effects of omega-3 fatty acids on all-cause and sudden mortality were similar to those observed in the total population of the trial.

The researchers believe that findings of this study should also be taken as a message to the public to eat more fish to keep their hearts healthy.

Official study title: A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure

For more information about omega-3 fatty acids, visit Vitaelin Nutraceuticals at http://vitaelinhealthcenter.com/

Sources

GISSI-HF investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008; DOI: 10.1016/S0140-6736(08)61241-6. Available online at: http://www.thelancet.com.
GISSI-HF investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008; DOI: 10.1016/S0140-6736(08)61241-6. Available online at: http://www.thelancet.com.
Fonarow GC. Statins and n-3 fatty acid supplementation in heart failure. Lancet 2008; DOI: 10.1016/S0140-6736(08)61239-8. Available online at: http://www.thelancet.com.
Kjekhus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007; DOI: 10.1056.nejmoa0706201. Available online at: http://www.nejm.org
Hjalmarson Å Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA)-Results of an outcomes trial in patients with ischemic heart disease and heart failure. American Heart Association 2007 Scientific Sessions; November 5, 2007; Orlando, FL, Late-breaking clinical trials 2.

Increased Dietary Choline May Reduce Breast Cancer Risk

2008-07-24T22:22:00.000-07:00

Finally some positive news about possible breast cancer reduction and the use of vitamins. A study conducted by a team of doctors including Dr Xinran Xu and Dr Marilie Gammon of the Department of Community and Preventive Medicine at the Mount Sinai School of Medicine, in New York, confirmed that greater intake of the B vitamin choline is associated with a reduction in the risk of breast cancer.

The study was funded by the National Institutes of Health (NIH) and published in the June 2008 edition of The FASEB Journal, the offical publication of the Federation of American Societies for Experimental Biology (Xu X, Gammon MD, Zeisel SH, Lee YL, et al , Choline metabolism and risk of breast cancer in a population-based study. FASEB J 2008 Jun;22(6):2045-52. Epub 2008 Jan 29).

"Choline metabolism may play an important role in breast cancer etiology..."

Choline is an essential nutrient required for methyl group metabolism, but its role in carcinogenesis and tumor progression is not well understood. The Scientists compared dietary intake data from 1,508 women with breast cancer with 1,556 women whoid not have the disease. They focused on choline and two other, related, nutrients, methionine and betaine, involved in methylation, which plays a role in cancer development [odds ratio (OR): 0.76; 95% confidence interval (CI): 0.58-1.00].

Women whose intake of choline was in the highest one-fifth of participants (>455mg/day) had a 24% lower risk of breast cancer than women whose intake was in the lowest fifth (<196mg/day). Despite choline’s importance for maintaining normal cellular function, only 10% of Americans are estimated to meet the Institute of Medicine’s adequate choline intake level of 425mg/day for women and 550 mg/day for men and breastfeeding women. This concerns the team as they believe that their 'findings suggest that choline metabolism may play an important role in breast cancer etiology'.

Food-, dietary supplements and vitamins: Know what you take!

2008-07-18T22:21:00.000-07:00

It’s a question that needs to be asked. If you are serious about your health and are taking food supplements, vitamins weight loss products and nutraceuticals do you know what you take? Do you know how these product impact your health? Are all these products good for your health? These seems simple, and easy questions, but the answer is very important. In this blog I'll try to explain.

Knowing what you take to improve your health requires having access to trustworthy information. As distributors of food- and dietary supplements we tell our customers that they can trust the products we sell. We feel very comfortable in educating our clients about our products. We feel that it’s our responsibility to give them access to information so that they can research and indeed feel confident that what we tell them is in fact true.

"It's our responsibility to give ...information... and feel confident that what we tell them is in fact true!"

Unfortunately, not every vitamin and dietary supplements is good for your health. But how do you know? There are various resources available. Some of these resources are available online, for other resources and information a trip to your local library may be required. But whatever the case, we feel that every consumer needs to make sure that he/she knows about the product they are taking.

One resource I really like is from The International Bibliographic Information on Dietary Supplements. This information is generated by various agencies from the US government. But there are also many European and national resources worth reading.

Naturally, as a senior consultant of the European division of Vitaelin Nutraceuticals, I'll make sure that information that impacts any of the products we distribute is immediately released to the public. That's, what I feel, is my duty: be honest and fair in health education and information. But, at the same time we encourage our clients to continue researching all the products they take.

A great Database
As mentioned, we like the resources from The International Bibliographic Information on Dietary Supplements (IBIDS). The database prepared by this organization is very complete. It provides access to bibliographic citations and abstracts from published, international, and scientific literature on dietary supplements. IBIDS is collaboration between two US government agencies: the Office of Dietary Supplements of the National Institutes of Health, and the Food and Nutrition Information Center (FNIC) of the United States Department of Agriculture's (USDA) National Agricultural Library (NAL).

What is the IBIDS Database?
The International Bibliographic Information on Dietary Supplements database is an easy to search free of charge internet resource. It is a collaboration between two government agencies: the Office of Dietary Supplements, National Institutes of Health (NIH) and The Food and Nutrition Information Center (FNIC), The National Agricultural Library (NAL), Agricultural Research Service (ARS), United States Department of Agriculture (USDA)

The database is a "work in progress" with new search terms, abstracts and citations added quarterly and modifications made to the search approach to respond to suggestions from users

Content
As of September 2007 there are over 760,000 citations on the topic of dietary supplements from four major database sources: biomedical-related articles from MEDLINE, botanical and agricultural science from AGRICOLA, worldwide agricultural literature through AGRIS, and coverage of international applied life sciences literature from CAB Abstracts and CAB Global Health.

Scope
The database generally lists the use and function of vitamin, mineral, phytochemical, botanical, and herbal supplements in human nutrition.It also lists the role of nutrient supplementation in metabolism in normal nutrition and disease states. Furthermore, animal studies that relate to the function of dietary supplements in human nutrition, chemical composition, biochemical roles, and antioxidant activity of botanical and nutrient supplements and fortification of foods with supplemental nutrients and health-related effects are reported.

The database also lists:

Nutrient composition of herbal and botanical products;
Surveys on dietary supplement use by various populations;
The growth and production of herbal and botanical products used as dietary supplements;
Abstracts where permission has been granted from the publisher;
Citations from 1986 to the present
Citations in foreign languages, if the abstract is in English;
Citations have been selected from multiple databases to ensure that the database is comprehensive and internationally representative;
Full, peer-reviewed and consumer journal databases;
Keywords to help you find your topic of interest
In the future -- citations from additional database sources.

In addition to having records on substances used as dietary supplements, IBIDS also includes records on substances such as niacin and glucosamine used in situations where they may be considered drugs. Such records are included in order to provide information on mechanism of action, possible adverse effects, and other information of potential interest to IBIDS users.

What does the IBIDS database not contain?

Full journal articles - these may be obtained through your local public or university library or online through journal websites or document delivery services
All herbal and botanical supplement ingredients - the American Herbal Products Association estimates that there are over 2000 herbal ingredients available in supplement products in the United States. The IBIDS database began with literature on the top 50 botanicals identified by the European Union and now contains literature on over 250 botanicals. These include the best sellers in the U.S. market.
Complementary and alternative medicine approaches such as homeopathy, chiropractic, massage, and acupuncture. For more information on these topics, contact the National Center for Complementary and Alternative Medicine.

Conclusion
The IBIDS database is just one of the resources we like. There are more resources dealing with information about supplements related to health and healthcare. In the weeks ahead I’ll discuss other resources as well.

If you have any questions or comments, you can contact me directly by sending us an email. For more information visit our website at Vitaelin Nutraceuticals.