HEALTH

Study: 2,000 IUs of vitamin E daily effective in slowing functional decline in AD patients

BY Michael Johnsen

CHICAGO — Among patients with mild to moderate Alzheimer disease, a daily dosage of 2,000 IUs of vitamin E, compared to placebo, was effective in slowing functional decline and in reducing caregiver time in assisting patients, according to a study that appeared in the Jan. 1 issue of the Journal of the American Medical Association.

"These results point to a powerful role of integrating proper nutrition into disease management, and provide hope for Alzheimer’s patients and their care givers," saidd Duffy MacKay, VP scientific and regulatory affairs for the Council for Responsible Nutrition. "However, the dietary supplement industry should be reminded that dietary supplements cannot be marketed or sold to consumers as a disease treatment, and we recommend that those suffering with Alzheimer’s disease rely on the advice of a trusted doctor as to the appropriate treatment plan. Self-dosing at the levels studied in this trial are not recommended."

Alpha tocopherol, a fat-soluble vitamin and antioxidant, has been studied in patients with moderately severe Alzheimer disease and in participants with mild cognitive impairment, but has not been studied in patients with mild to moderate AD. In patients with moderately severe AD, vitamin E was shown to be effective in slowing clinical progression. 

The drug memantine has been shown to be effective in patients with AD and moderately severe dementia, according to background information in the article.

Maurice Dysken of the Minneapolis VA Health Care System and colleagues examined the effectiveness and safety of vitamin E, memantine and the combination for treatment of functional decline in patients with mild to moderate AD who were taking an acetylcholinesterase inhibitor (a chemical that increases the level and duration of action of the neurotransmitter acetylcholine). The trial included 613 patients at 14 Veterans Affairs medical centers. 

Over the average follow-up time of 2.3 years, participants receiving vitamin E had slower functional decline than those receiving placebo, with the annual rate of decline in ADLs reduced by 19%. This treatment effect translates into a clinically meaningful delay in progression in the vitamin E group of 6.2 months. 

Neither memantine nor the combination of vitamin E and memantine showed clinical benefit in this trial.

In addition, caregiver time was reduced by about two hours per day in the vitamin E group.

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FDA cracks down on illegal concussion claims

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday. 

"The Food and Drug Administration is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms — the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment or prevention of disease," the agency stated. "The agency also is warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat or cure concussions and other traumatic brain injuries because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and are marketed to consumers using social media, including Facebook and Twitter."

One common claim is that a particular dietary supplement promotes faster healing times after a concussion or other TBI. "Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous," stated Gary Coody, FDA’s National Health Fraud Coordinator. "We’re very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," he said. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities — such as football, soccer or hockey — too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with consequences that can include brain swelling, permanent brain damage, long-term disability and death.

"As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster," added Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs. 

One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense. "We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," said Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. "That sparked our surveillance."

Typically, products promising relief from TBIs tout the benefits of such ingredients as turmeric and high levels of omega-3 fatty acids derived from fish oil.

In December 2013, FDA issued a warning letter to Star Scientific for marketing its product Anatabloc with claims to treat TBIs.

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NBTY donates nearly $7 million in products, money throughout 2013

BY Michael Johnsen

RONKONKOMA, N.Y. — In 2013, NBTY supported more than 30 organizations, including Feed The Children and International Aid, with nearly $7 million in products and money to provide sustenance, nutrition and support to those who need it most, the supplement manufacturer announced Thursday. 

NBTY’s donations to Feed The Children are estimated to have reached almost 450,000 beneficiaries, the company stated.  

In addition, for the seventh year, NBTY manufactured and packaged a proprietary blend of vitamins to be distributed worldwide through Vitamin Angels. In 2013, NBTY provided Vitamin Angels with enough children’s chewable daily multivitamins to reach nearly 123,000 children in 23 countries, including 18 U.S. states. 

Also in 2013, NBTY Helping Hands supported a variety of organizations, including Long Island Cares, 9-1-1 Veterans, Big Brothers Big Sisters, Long Island Blood Services and the Ski’s Open Heart Foundation. The organization purchased, filled and donated more than 3,000 backpacks to help underprivileged children return back to school in the fall. Donations allowed Long Island Cares to build a new facility in Lindenhurst, N.Y., provided scholarships to children through Big Brothers Big Sisters and provided Thanksgiving meals to veterans and their families for the holidays through 9-1-1 Veterans.

"All of us at NBTY take a great deal of pride in being able to reach out and support our local and global communities in such a profound way," stated Jeff Nagel, CEO of NBTY. "Beyond our products, our associates donate their own time and effort to make many of these donations possible and to figure out ways to give back. We are a company that believes in wellness, and I’m proud that we are able to truly get behind our wellness mission by helping others."

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