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The New Mind Set
Natural Alternatives for Treating Memory Loss
and Migraines in Customers of All Ages


By Rich Handley
September 2003

Memory and concentration issues are a growing concern for many Americans. Memory function, alertness, learning, and concentration are vital, yet so many suffer deficiencies in these areas. On top of that, migraine headaches continue to affect a wide portion of the population. What can be done about these conditions from a natural health standpoint?
What markets are there for such alternatives, what products are available, and what side effects and contraindications affect customers across different age groups?

FOCUS AND CONCENTRATION
Robert M. Krakoff is the President of MindFX Science LLC (based in Ajijic, Jalisco, Mexico), a firm whose natural vitamins and herb products address problems involving concentration and focus for competitive athletes, college students, and professionals under stress, without the use of harsh stimulants. "Everyone," he says, "is subjected to stress of everyday living.

Everyone is exposed to toxins and pollution." MindFX markets three products to help deal with such stress: Maxx Impulse, NeuroCharge, and Aftermath. Maxx Impulse is an energy enhancer containing guarana, green orange, and cacao fruit extract, Krakoff says. It uses adaptogenic herbs and is designed to provide sustained energy and concentration without high doses of caffeine or ephedra-like ingredients. "There is no rush," he adds, "no jolt, or nervousness." NeuroCharge, a multi-stage brain support complex, consists of ginkgo biloba, huperzine, and vinpocetine, all thought effective for hand-eye coordination and detail-oriented work. Aftermath, meanwhile, is intended to improve recuperation and relaxation, with a formula based on vitamins B complex and C. Non-athletes, he adds, have also reported its benefit in overcoming sleep disorders.

Dr. Patsi Krakoff, vice president of MindFX Science, says her company is setting up a double-blind, placebo-controlled study through a major university graduate department to test and measure the effectiveness of Maxx Impulse and NeuroCharge. "As these two products are designed to get results for competitive sports people," she predicts, "we are convinced studies will be able to measure, with a high degree of validity, their actual effectiveness under laboratory conditions."

Patsi Krakoff also insists there are no side effects for any natural ingredients MindFX uses. "We do caution people who have a high sensitivity to caffeine or caffeine-related stimulants and others who may have heart conditions of a highly sensitive nature to consult with a physician before taking any products. Because our actual stimulant effect may be comparable to a half-cup of coffee, adverse side effects would be extremely rare and unusual."

On the other hand, pharmaceuticals used for attention and concentration can be "harsh on the system," even addictive, she points out. Still, some dangerous stimulants such as Ritalin and Adderall, used indiscriminately by college students, have found their way into the street drug market.

Parris M. Kidd, Ph.D., from Science & Ingredients Inc., Carlsbad, Calif., recommends phosphatidylserine (PS) and glycerophosphocholine (GPC) for memory and concentration loss, respectively. In 12 double-blind experiments, says Dr. Kidd, PS has been shown effective for memory support and even partial restoration of memory in people over age 50. In fact, a November 2002 column entitled "Can a Pill Boost Your Memory?" in the Wall Street Journal deemed PS the most effective ingredient for memory improvement.

"Double-blind trials," Kidd adds, "prove GPC's usefulness for concentration and alertness in young, healthy subjects, as well as those of advanced age." GPC has been touted for its benefit to mental performance in those with circulatory problems, and for helping stroke and brain damage victims recover their memories. "The consistent safety of these substances," claims Kidd, "is likely related to their being orthomolecules - molecules occurring naturally in our cells (and sometimes manufactured by them), therefore orthodox to the body."

PS has been administered to children as part of an integrative program for managing attention and behavioral problems, while GPC is abundant in breast milk and a source of the essential nutrient choline. Both PS and GPC are compatible with pharmaceutical drugs, and both contribute to the reservoirs of phospholipids essential to tissue growth, expansion, and repair.

According to Kidd, many studies back up PS's ability to improve memory function, learning, concentration, and alertness. The most telling, he feels, have been two double-blind trials by Dr. Thomas Crook and collaborators, and a large double-blind trial by a group in Italy led by a Dr. Cenacchi. Crook, a memory researcher, found that PS might "turn back the clock on aging" in subjects with severe memory decline, but not yet advanced to dementia. The Cenacchi trial, meanwhile, established that PS did benefit memory, and that it was "extremely well-tolerated" and "did not interfere with a variety of drugs most commonly used by the elderly."

As for GPC, Kidd says, many studies have shown its use involving problems with alertness, concentration, learning, and memory. "Its benefits were assessed in a recent review by Dr. Lucilla Parnetti in Mechanisms of Aging and Development, Volume 122. Notably, GPC can improve alertness and concentration even in young healthy subjects."

Another orthomolecule, citicoline, may also be useful in countering memory loss. A precursor to phosphatidylcholine, citicoline is broken down into uridine and choline when absorbed by the body. It then reforms in the brain and is used as raw material for phosphatidylcholine synthesis. This substance is used in treating, among other conditions, disorders of a cerebrovascular nature. It has been used in many European countries and Japan for cognitive impairment and brain metabolism activations, and several studies have cited positive results in improving memory and performance.

AGE-RELATED MEMORY LOSS
"It seems," asserts Cheryl Myers, director of product development at Green Bay, Wis.-based Enzymatic Therapy, "that memory decline and problems with mental focus are a normal part of aging." Alzheimer's disease, for example, is an irreversible, progressive disorder that slowly kills nerve cells in areas of the brain where memory, learning, thought, and language take place. While this illness is far from curable, she adds, it may be prevented. "Recently, impressive and extensive research has shown that Alzheimer's disease has some important nutritional links. In fact, high intake of folic acid, one of the B vitamins, has been shown to actually reduce the risk of developing the disease. Folic acid is a vital nutrient for support of healthy brain and spinal cord function, and scientists have recognized that individuals with low folic acid levels can exhibit several serious health problems."

One of the most researched herbs, Ginkgo biloba, has been studied in individuals who have age-related memory loss, and in those with Alzheimer's disease and similar dementias. According to Myers, ginkgo may improve many brain functions, speeding up memory recall, protecting brain cells from chemical changes and free radical damage, improving blood flow to the brain, and helping nerve cells communicate with each other.

It should be noted that the Journal of the American Medical Association concluded in a recent study that ginkgo provides "no measurable benefit in memory or related cognitive function." Immediately following this published report, the National Nutritional Foods Association, American Botanical Council, Council for Responsible Nutrition, and American Herbal Products Association issued statements that urged people to consider the fact that ginkgo has been shown in the past to be effective for both healthy and cognitively impaired patients in more than 120 clinical studies.

Also, those taking ginkgo and blood-thinning medications together should consult a healthcare practitioner, as both the Physician's Desk Reference for Herbal Medicines and The Complete German Commission E Monographs have indicated the use of ginkgo may interact with such medications. Myers points out that other than blood-thinning and occasional gastric upset, few adverse effects are attributed to products offered by her company, which include Remember!, Concentrate, and Rhodiola Energy formulas.

The herb Bacopa monnieri, grown in India, also supports memory and focus. "In a recent study," Myers recalls, "bacopa was compared to a placebo in its effect on memory. The group taking the bacopa extract was able to remember new information much better than the group taking the placebo." Bacopa contains saponins, hersponin, and bacosides, which can help relieve anxiety, restlessness, and stress-induced forgetfulness. Herbs with similar uses include ashwaganda (a stress and fatigue protectant) and gotu kola (which promotes collagen production, increasing mental alertness by supporting brain capillaries).

Himalaya USA of Houston, Texas, produces a line of supplements called MindCare that blends these herbs to improve memory and cognitive function, while Nature's Life of Garden Grove, Calif., uses them in its Mental Vitality supplement, along with acetyl-L-carnitine, phosphatidylserine, dimethlyaminoethanol (DMAE), vitamins B6 and B12, Ginkgo biloba, American ginseng root, and milk vetch.

Alpha lipoic acid (ALA) has been reported to work "especially well" with other antioxidants. "Researchers have discovered unmistakable free radical damage in Alzheimer's," says Myers. "Accordingly, ALA's effect in memory and focus has been studied extensively. Researchers have learned that ALA not only prevents free radical damage, but also supports the health of protective chemicals in the brain. Like ALA, vitamins B6 and B12 support healthy homocysteine levels."

Of course, natural products are not the only way to address age-related memory loss. In a June 2003 report on CNN.com, a study was said to show evidence that stimulating the mind can ward off Alzheimer's and other forms of dementia, much like how physical exercise keeps the body fit. In the study, conducted at New York City's Albert Einstein College of Medicine, researchers sought to establish that keeping mentally active can help guard against dementia.

MENOPAUSE AND OTHER CONDITIONS IN WOMEN
Myers says Enzymatic Therapy is concerned with healthy memory and concentration, and how these mental functions change as people age, particularly in women. For young adults, Myers says, memory and concentration problems are "quite unique." One alternative Enzymatic Therapy offers is Doctor's Choice for Women, a multivitamin that provides vitamins, minerals, and nutrients designed to help younger customers concentrate and stay focused. Memory and focus issues in women are often nutritional, Myers says, and that continues on into adulthood.

"As a woman enters perimenopause," she adds, "generally between the years of 45 and 50, she may experience extremely frustrating episodes of forgetfulness and poor concentration. That's because her ovaries are slowly secreting less and less of the sex hormones estrogen and progesterone."

For some middle-aged women, the first symptoms of perimenopause are these lapses in memory and focus, so-called "fuzzy thinking" that can be addressed nutritionally. To that end, Myers says, Enzymatic's AM/PM Menopause Formula is a two-tiered supplement containing green tea, panax ginseng, and black cohosh. The latter helps reduce hot flashes, while the green tea and ginseng support alertness and energy. The PM tablet, meanwhile, contains valerian, hops, L-theanine, and additional black cohosh.

Green tea is also among the ingredients in Jarrow Formulas' Neuro Defense, a supplement intended to help protect brain and cardiovascular metabolism. Other ingredients include apigenin, silymarin, niacinamide, grapeseed OPC, and phosphatidylcholine. The first two inhibit Mitogen-Activated Protein Kinase (MAPK) cascade enzymes, which are activated by oxygen deficiency; the B vitamin niacinamide protects brain cell DNA by countering NAD enzyme depletion; and green tea and grapeseed provide antioxidant protection for neurons.

For menstrual-related memory problems, Kidd recommends two long-chain omega-3 fatty acid anti-inflammatories, EPA and DHA. "Since inflammation has now been indicted in Alzheimer's, as well as ADHD, autism, multiple sclerosis, and Parkinson's, their role becomes more centerstage." One anti-inflammatory nutraceutical product, Neptune Krill Oil (created in Laval, Canada, by Neptune Technologies & Bioresources) contains EPA and DHA in activated form, along with phospholipids and potent antioxidants. Both fatty acids reportedly support a healthy cardiovascular system and stabilize emotional symptoms related to psychological conditions and stress. According to Kidd, a double-blind clinical trial indicated its benefits regarding "the emotional and physical discomforts associated with the menstrual cycle" (Sampalis and others, Alternative Medicine Review, Volume 8, p. 171, 2003).

BETTER LEFT FORGOTTEN?
Very few drugs have been approved in the United States for use against memory loss or its most severe expression, dementia. Dr. Kidd reports that tacrine was the first drug approved for Alzheimer's dementia, while donezepil was the second. Both had more than their share of problems, however, making many wonder if the treatment was no better than the illness.

Tacrine was shown to cause serious liver injury in many patients, and was judged ineffectual by the Medical Letter on Drugs and Therapeutics in 1993, Volume 35. Though non-toxic to the liver, donezepil can cause nausea, diarrhea, vomiting, insomnia, fatigue, muscle cramps, and loss of appetite. In fact, in 1997 the Medical Letter, Volume 39, discounted this drug's effectiveness as well. Both tacrine and donezepil, says Kidd, are cholinesterase inhibitors; a more recently emergent and better-tolerated cholinesterase inhibitor is rivastigmine. Its adverse effects profile is similar to the others but reportedly somewhat milder.

One older Alzheimer's drug, ergoloid mesylates, may even worsen the disease, yet it has been on the market for more than 30 years. In 1991, the Journal of the American Medical Association deemed it of no value for Alzheimer's, while a 1990 study published in The New England Journal of Medicine concluded the drug might even accelerate the disease's progression. The latter's authors surmised that the drug may be directly toxic to the brain. Not surprisingly, Sidney M. Wolfe, M.D., and the watchdog Public Citizen's Health Research Group have classified all three of these drugs in the category "Do Not Use," according to Worst Pills, Best Pills (Pocket Books, 1999).

Of course, even natural alternatives can cause serious side effects. Kidd points out that ginkgo can cause bleeding in the brain, while vinpocetine is prepared from periwinkle, a plant not normally consumed by humans. Huperzine is prepared from the Chinese clubmoss and has a relatively narrow margin when it comes to safe dosages, and galantamine can cause nausea, vomiting, diarrhea, and dizziness; it also cannot be used by those with severe liver impairment.

To that end, retailers must keep customers educated on which natural health products to take for their own individual conditions, as well as any side effects and contraindications they should know about. In addition to the traditional promotional literature often supplied to stores, some manufacturers are taking a proactive role in helping retailers make this happen. Mark Lubin, president and chief scientist of Miami, Fla.-based Râ-Zen Relief, says his company supports in-store training for larger retail locations and is producing a CD-ROM for stores that will contain product highlights, science, and mechanisms.

Peter Rohde states that Science & Ingredients has taken similar actions. "The introduction of new products needs educational marketing by the raw material supplier. This means raw material suppliers have to take charge to assist the industry by creating the product, training their sales force, helping them develop their promotional material, and even producing printed material directly for the retailers. Initially, they are responsible for creating the market." One resource he recommends is HPB's own Retail Sales Instructor series.

MindFX's Robert Krakoff agrees. "We have offered retailers literature, train-the-trainer sessions, demonstrators, and speakers for large stores and store openings, as well as collateral materials. We are active in industry trade shows and offer ourselves as speakers to industry seminars."

CONCENTRATING ON THE FUTURE
Looking ahead to future markets and potential cross-marketing opportunities, Rohde predicts phospholipid product sales will increase, with cognition and memory products offering great opportunities due to the population's rapidly changing age structure.

One driving element in phospholipid sales, Rohde believes, will be the development of products based on new resources. Currently, phospholipids from marine sources are hitting the market rich in omega-3 fatty acids. Another approach will come from functionalizing phospholipids via enzyme technology. "This long-known technology, used [by] the food industry over decades, will create new products with newly defined properties and applications, backed up by clinical trials."

Robert Krakoff at MindFX agrees there is a growing market for brain enhancement supplements as the population ages. "Adults and children [alike] are more educated than ever before, and are now realizing that having a healthy brain will mean more energy [and] more ability to focus at both work and play." Taking care of the brain is a first step, he says, in providing energy to exercise, eat right, and be able to enjoy both physical and emotional health.

Râ-Zen's Lubin offers his insight: "In the next several years, the natural products market will grow tremendously because of several factors. An aging baby boomer population of middle-to-upper income, well-educated consumers will dramatically increase the number of people making more proactive decisions about their own healthcare."

He maintains that pharmaceutical companies should not have such a stranglehold on the medical community. "There's way too much of a 'kickback' nature that clouds doctors' clear thinking."

Rubin also believes that Western doctors should "get their heads unplugged from their butts" about how other people around the world have used natural medicine successfully for centuries in a sophisticated and established fashion.

For many who oppose the Natural Products Industry, that is certainly a statement worth remembering.

Rich Handley is the managing editor of Advanced Imaging and VDV World magazines and also freelances for several other publications.

Natural Migraine Relief
Pharmaceutical choices for treating migraine headaches fall into three major categories: prophylactic, abortive, and analgesic, says Mark Lubin, president and chief scientist of Miami, Fla.-based Râ-Zen Relief. Prophylactic drugs are taken every day and designed to prevent the onset of migraines by interrupting the physiology of their formation. Examples include amitriptyline, propanolol, and verapamil. Side effects include dry mouth and eyes, arrhythmias, hypotension, bradycardia, impotence, and others.

Abortive drugs are taken for an established headache - that is, one already in progress. Some examples cited by Lubin include ergotamine, dihydroergotamine, sumatriptan, zolmitriptan, and naratriptan, which can cause such possible side effects as nausea, vomiting, angina, hypotension, dizziness, fatigue, and others.

Analgesic drugs are used to alleviate pain symptoms "in the short term, until the headache can be corrected by a drug falling into one of the other two classes." The choices here, he says, are usually aspirin, acetaminophen, non-steroidal anti-inflammatory drugs like indomethacin and naproxen, or opoid drugs such as (but not limited to) oxycodone, codeine, methadone, morphine, nalbuphine, and meperidine. Side effects of these systemic opiates include overall sedation, constipation, hepatic toxicity, dyspepsia, gastrointestinal bleeding, nausea, and diarrhea.

So, what can a person experiencing a migraine headache take without having to resort to questionable drugs? "To the best of my knowledge," Lubin says, "all natural remedies except for Migra-Zen Relief PLUS [a product marketed by his company] use either the herb feverfew, Tanacetum parthenium, or extracts thereof." Migra-Zen Relief PLUS, meanwhile, uses juniper berry, goldenrod flower, dandelion leaf, meadowsweet plant, and willow bark infused into golden raisins. Rubin adds that each of these herbs has been in common use in at least one of the four major herbal medicine traditions (Chinese, Indian, European - including Egyptian and Middle Eastern - and Native American) for more than 3,500 years, with reports of their effectiveness in treating migraine discomfort abound in many herbal texts written over that period of time.

Dr. Patsi Krakoff says that while her firm does not actively target consumers with medical conditions prone to headaches, "users have been known to get rid of headaches by using Maxx Impulse." MindFX is looking into finding out why this 'side-effect' occurs, she explains. "Some of our product ingredients have been tested on aging subjects [as well as] those with Parkinson's and Alzheimer's with good results; however, data from that study is incomplete. Our ingredients have natural vasodilator effects on the brain, increasing blood flow and oxygen to the neurons."

Cheryl Myers claims that published clinical trials of a patented form of standardized butterbur extract have illustrated the ingredient's efficacy in migraine prevention. In one study published in the April 2003 issue of the Townsend Letter, more than 80 percent of the participants (13 of 16) experienced a clear and substantial benefit in migraine relief, while the mean number of migraine hours experienced also declined a substantial 54 percent. What's more, 75 percent of the participants rated their migraine symptoms as "better" or "clearly improved." The second phase of this study, involving a much larger group of patients in a multi-center trial, is currently underway.

It should be noted that butterbur contains pyrrolizidine alkaloids (PA), chemical compounds that naturally occur in many plant species. Unfortunately, ingestion of plants with PA content can result in significant health problems. Myers reports that a special butterbur extract - the same used in the clinical studies discussed above - is produced through a patented process that removes the pyrrolizidine alkaloids. Its safety was evaluated in a recent article in Headache: the Journal of Head and Face Pain, which showed that the only significant side effect reported was eructation (burping). "PA-free butterbur extract," says Myers, "has also shown excellent safety and tolerability in children as young as six years old." In addition, "the reviewers calculated that the overall frequency of adverse reactions is only 0.022 percent."

Reposted with permission from Health Products Business magazine

Here's what some of the top editors are saying about MindFX products:

"I took Maxx Impulse ($29), Neurocharge ($29) and Aftermath ($19) for a few
weeks. I can't say I've developed abs of steel – or even thumbs of iron –
but all my major organs seem to be functioning. And having a couple extra
vitamins, minerals and herbal supplements in my daily diet can't hurt."
Read the full article

"I was getting consistently low scores in Sega's new 3-D shooter Panzer
Dragoon Orta. There are so many enemies flying around, it's hard to
prioritize targets and then hit every last one. Neurocharge seemed to make
it easier to quickly and accurately multitask."
Read the full article

PC Gamer piece was great. They did a head-to-head mini-LAN battle with two of their in-house game/console testers - one taking Maxx Impulse and the other taking a placebo - Certs breathmints! The tester on Maxx Impulse scored a significantly higher amount of frags and had an increased level of energy while the other tester lost big and came out with a sore thumb. We surmise that the loser at least had better smelling breath.

Copyright © 2003, Mind-FX Inc.