Assessment of Liver Toxicity Cases Associated with Black Cohosh Concludes Lack of Causality

In the past several years, there have been numerous reports of possible liver toxicity associated with the use of various preparations made from black cohosh (Actaea racemosa, Ranunculaceae, syn. Cimicifuga racemosa), popular for treating symptoms associated with menopause.

Although some regulatory agencies and related bodies have reviewed these cases and have announced some preliminary cautions (for example the European Medicines Agency [EMEA]), critical analyses have questioned the causality of such cases.

Pharmacoepidemiological experts from the Teaching Hospital of the Johann Wolfgang Goethe University of Frankfurt/Main, Hanau, Germany, analyzed case reports which regulators have previously considered "possible" or "probable" in causality with black cohosh.

After analyzing 4 cases:

The clinical analysis and structured causality assessment reveal that in one patient there was no valid evaluation possible due to lack of basic information and the remaining 3 cases had no convincing evidence that the liver diseases were caused by black cohosh. These 3 patients were all treated with steroids for acute drug-induced hepatocellular jaundice and fulminant liver failure. The authors note that there is no evidence of steroids’ benefiting this condition, and that since early antiviral therapy is necessary for herpetic liver disease, steroid therapy should not be considered unless all viral causes have been safely excluded. It is fascinating that the reanalysis of the data showed that the EMEA drew inaccurate conclusions. Vigorous causality assessments using a diagnostic algorithm are essential to determine causality for any severe adverse event.

Click Here to download the complete article review from HerbClip, the American Botanical Council.

© 2009 Teschke R, Schwarzenboeck A. Suspected hepatotoxicity by Cimicifugae racemosae Phytomed. rhizome (black cohosh, root): Critical analysis and structured causality assessment. 2009;16: 72-84: http://cms.herbalgram.org/herbclip/372/review020591-372.html

Spring allergy relief with natural remedies

Springtime allergies can put a damper on even the sunniest day. But—they don’t have to. If you’ve relied upon store-bought allergy medications in the past—and have been disappointed—this is the season for a more holistic approach to allergies.

Studies show that allergies are often a reaction to a combination of things. For many, budding spring plant life and pollen are irritants. But other, more hidden irritants include: food allergies, environmental irritants (such as, chemical-based cleaners, room sprays, and dryer sheets), and dust.

The good news: There are several alternative products and strategies you can use to sooth your allergies. The benefits: health tools like supplements, herbs, essential oils, and lifestyle modifications are natural, cost effective, and can work fairly quickly to bring relief.

Here are 8 tips for tackling your allergies naturally:

1. Incorporate native plants into your diet.
2. Eat 1-2 tablespoons of local, raw honey every morning.
3. Diffuse peppermint essential oil throughout your home and, or office.
4. Add fresh herbs to a hot bath and deeply breathe in the steam.
5. Take supplements, including: echinacea, goldenseal, and vitamin C.
6. Clean and dust regularly. You don’t have to use chemicals; a steam mop works great.
7. Exercise. Physical activity strengths the body and boosts immunity. Try to exercise outside in the early morning, before allergens kick up.
8. Facial massage is a simple way to relive pressure built-up in the sinus.

For more information about holistic nutrition or soothing allergies with homeopathic remedies, visit the Australasian College www.achs.edu.

Growing vegetables relieves stress and financial strain

When tough economic times hit, our collective money belts cinch tighter and tighter. People stop looking for entertainment out of doors and hunker down for the at-home experience, including eating in.

Yet—there is a silver lining. Although the current economy may cause us to make the move from sidewalk café to sideboard jockey (for a while), there is much to gain along the way. Say hello to stress relief. It may sound counterintuitive—“I’m stressed because everyone is stressed, so I should be frugal and grocery shop and stay home and cook my own dinner.”

But, cooking—and by extension, growing your own food—is an age-old holistic health practice, which promotes relaxation by shifting your focus from mental worry to physical exertion. As anxiety chills, your immune system and cardiovascular systems work better (otherwise known as, “I feel good.”)

It’s a win-win. You feel better AND your wallet feels better, because GIY (grow-it-yourself) gardening gives you fresh vegetables at a fraction of the store-bought price.

How do you get started?

Seed starting. True, you can also save money with month-old plants from your local nursery or home-supply store, but why would you? Seeds are a fraction of the price and produce more of what you want—lots’o’veggies.

One of the best ways to seed start, according to Master Gardener and ACHS Senior Vice President Erika Yigzaw, is with a seedling heat mat. These mats are portable and lightweight (which means apartment friendly), and allow you to bottom water, minimize the risk of mold.

Seed starting, Yigzaw shared at the ACHS Organic Gardening workshop March 21, has several personal and health benefits:

• It’s fun and easy.
• Fresh, on-hand food.
• You know where your food comes from (if you spend a little time researching your seeds and seed starting mix, you can be sure your food is organic, free of synthetic pesticide and chemicals).
• Saves money.
• Lengthens the growing season.

Start gardening...

1. Check the Farmer’s Almanac for your region to see when the last frost is scheduled to arrive.
2. Consult a gardening encyclopedia-type reference to see what veggies will grow best in your area. (In Oregon, the Oregon State University Master Gardener program is a good resource.)
3. Find your local, organic gardening store, where you can purchase your seeds, seedling starting mix, and seedling heat mat.
4. Read any and all instructions that come with your products.
5. When it is time to replant your seedlings into larger containers, re-use household materials like old plastic and/or ceramic planters, bowls, glasses, or tubs.
6. If you plan to transplant your veggies into larger plots, consult a local expert in advance. If you plan to build a container garden, the Gardener’s A-Z Guide to Growing Organic Food is a very user-friendly resource.

Tip: Make sure the container is large enough to avoid root-bound plants. And, you will want to sterilize your containers in a 10% solution of bleach.

For questions about organic, at-home gardening, contact the OSU Master Gardeners or your local organization.

For information about personal nutrition, or holistic nutrition career training, contact the Australasian College of Health Sciences.

Debate over the future of NCAAM takes to the blogs

The National Center for Complementary and Alternative Medicine at the National Institutes of Health (NCCAM), which was established about 17 years ago and provides some of the best studies about homeopathy, acupuncture, therapeutic touch, and herbal medicine, is under fire from the scientific community.

Why now? Economics. Scientists are using the nation's economic hardships as a ballast for a negative campaign against alternative and complementary medicine modalities. Their argument: With funding scare, why should the National Institutes of Health fund a "pseud0-science."

We'd love to hear your thoughts about the article below. "Pseudo-science" or viable alternative to rising health care costs and effective, educative tool about prevention?? Hmmmm.......... we wonder.

According to "Critics Object to 'Pseudoscience' Center," a March 17 article in the Washington Post:

The impending national discussion about broadening access to health care, improving medical practice and saving money is giving a group of scientists an opening to make a once-unthinkable proposal: Shut down the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

The notion that the world's best-known medical research agency sponsors studies of homeopathy, acupuncture, therapeutic touch and herbal medicine has always rankled many scientists. That the idea for its creation 17 years ago came from a U.S. senator newly converted to alternative medicine's promise didn't help.

Although NCCAM has a comparatively minuscule budget and although it is a "center" rather than an "institute," making it officially second-class in the NIH pantheon, the principle is what mattered. But as NIH's budget has flattened in recent years, better use for NCCAM's money has also become an issue.

"With a new administration and President Obama's stated goal of moving science to the forefront, now is the time for scientists to start speaking up about issues that concern us," Steven Salzberg, a genome researcher and computational biologist at the University of Maryland, said last week. "One of our concerns is that NIH is funding pseudoscience."

Salzberg suggested that NCCAM be defunded on an electronic bulletin board that the Obama transition team set up to solicit ideas after November's election. The proposal generated 218 comments, most of them in favor, before the bulletin board closed on Jan. 19.

NCCAM has grown steadily since its founding in 1992, largely at the insistence of Sen. Tom Harkin (D-Iowa), as the Office of Alternative Medicine (OAM) with a budget of $2 million. In 1998, NIH director and Nobel laureate Harold Varmus pushed to have all alternative medicine research done through NIH's roughly two dozen institutes, with OAM coordinating, and in some cases paying for, the studies. Harkin parried with legislation that turned OAM into a higher-status "center" (although not a full-fledged "institute"), and boosted its budget from $20 million to $50 million. NCCAM's budget this year is about $122 million.

Research in alternative medicine is done elsewhere at NIH, notably in the National Cancer Institute, whose Office of Cancer Complementary and Alternative Medicine also has a budget of $122 million.

The entire NIH alternative medicine portfolio is about $300 million a year, out of a total budget of about $29 billion. (NIH will get an additional $10.4 billion in economic stimulus money over the next two years, of which $31 million is expected to go to NCCAM.)

Critics of alternative medicine say the vast majority of studies of homeopathy, acupuncture, therapeutic touch and other treatments based on unconventional understandings of physiology and disease have shown little or no effect. Further, they argue that the field's more-plausible interventions -- such as diet, relaxation, yoga and botanical remedies -- can be studied just as well in other parts of NIH, where they would need to compete head-to-head with conventional research projects.

The critics say that alternative medicine (also known as "complementary" and "integrative" medicine, and disparagingly labeled "woo" by opponents) doesn't need or deserve its own home at NIH.

"What has happened is that the very fact NIH is supporting a study is used to market alternative medicine," said Steven Novella, a neurologist at Yale School of Medicine and editor of the Web site Science-Based Medicine (http://www.sciencebasedmedicine.org), where much of the anti-NCCAM discussion is taking place. "It is used to lend an appearance of legitimacy to treatments that are not legitimate."
Beyond the Blogosphere

So far, most of the debate has occurred in the blogosphere. But as health-care reform moves toward center stage, so may this fight.

At a Senate committee hearing on integrative medicine held Feb. 26, Harkin said: "I want to lay down a . . . marker: If we fail to seize this unique opportunity to adopt a pragmatic, integrative approach to health care, then that, too, would constitute a serious failure."

At the hearing, Harkin introduced Berkley W. Bedell, a six-term Democratic congressman from Iowa who retired in 1987 after contracting Lyme disease. Bedell credits alternative therapies for his recovery from that infection and later from prostate cancer. He helped convince the Iowa senator of alternative medicine's promise.

Nevertheless, Harkin said he was somewhat disappointed in NCCAM's work.

"One of the purposes when we drafted that legislation in 1992 . . . was to investigate and validate alternative approaches. Quite frankly, I must say it's fallen short," he told the committee.

"I think quite frankly that in this center, and previously in the office before it, most of its focus has been on disproving things, rather than seeking out and proving things."

Critics say this shows Harkin's lack of understanding of scientific inquiry, which tests hypotheses (with negative results as informative as positive ones) but doesn't intentionally attempt to "validate approaches." NCCAM's current director, Josephine P. Briggs, agrees that hypothesis-testing is the proper function of the center.

"We are not advocates for these modalities," she said last week. "We are trying to bring rigor to their study and make sure the science is objective."

Even so, Harkin was on to something: Most of NCCAM's results have been negative or inconclusive, not positive and encouraging.

For example, a randomized controlled trial of the botanical echinacea published in 2003 found it was ineffective in treating upper respiratory infections (although it did cause more rashes). In a study from last year, neither the Japanese "palm healing" therapy known as reiki, nor sham reiki, reduced the symptoms of fibromyalgia, a chronic pain syndrome. A study in December comparing real and sham acupuncture in 162 cancer patients who'd undergone surgery found no difference in their levels of pain.

At the same time, it's difficult to determine the clinical implications of some of the positive studies.

For example, reiki -- but not sham treatment -- blunted the rise in heart rate, but not the rise in blood pressure, in rats put under stress by loud noise. Therapeutic touch, a different modality, increased the growth of normal bone cells in culture dishes, but decreased the growth of bone cancer cells.

Many NCCAM-funded studies examine not the effectiveness of alternative medicine but its use, and how it affects the interaction of practitioners and patients. The idea that the center is spending lots of money running large clinical trials of such practices as homeopathy and ayurvedic medicine "is a misperception," the director said. She noted that most such proposals lack methodological rigor and aren't approved.

A physician and kidney specialist who never used alternative medicine in her practice, Briggs said "mind-body management for pain control and stress reduction" is a large topic of the research at the moment, with mindfulness, meditation, yoga and tai chi all under study.

"Some of the way these approaches work is through 'positive expectancy,' which is part of a placebo effect," she said.

Indeed, many of NCCAM's critics view complementary medicine as nothing more than the placebo effect dressed up in a dozen different costumes.

Carlo Calabrese, a researcher at the National College of Natural Medicine in Portland, Ore., one of the country's five naturopathic medical schools, isn't one of them. But even if one were to concede that view, he thinks the field is still worth studying.

Although the overall effect of therapies such as homeopathy and acupuncture may be small, individual response can be large. The route to the placebo effect -- if that's what it mostly is -- also varies in method and efficiency.

"What can be done to generate a better placebo? Why isn't that an interesting and valid area of investigation?" said Calabrese, who was on NCCAM's advisory council from 2004 to 2007. "Here we have a totally harmless intervention that seems to get a better result in some people than others. Why wouldn't you want to study that?

© The Washington Post March 17, 2009: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/16/AR2009031602139.html

Obamas to Plant Vegetable Garden at White House

WASHINGTON—Michelle Obama will begin digging up a patch of the South Lawn on Friday to plant a vegetable garden, the first at the White House since Eleanor Roosevelt’s victory garden in World War II. There will be no beets— the president does not like them—but arugula will make the cut.

While the organic garden will provide food for the first family’s meals and formal dinners, its most important role, Mrs. Obama said, will be to educate children about healthful, locally grown fruit and vegetables at a time when obesity and diabetes have become a national concern.

“My hope,” the first lady said in an interview in her East Wing office, “is that through children, they will begin to educate their families and that will, in turn, begin to educate our communities.”

Twenty-three fifth graders from Bancroft Elementary School in Washington will help her dig up the soil for the 1,100-square-foot plot, in a spot visible to passers-by on E Street. (It is just below the Obama girls’ swing set.)

Students from the school, which has had a garden since 2001, will also help plant, harvest and cook the vegetables, berries and herbs. Virtually the entire Obama family, including the president, will pull weeds, “whether they like it or not,” Mrs. Obama said with a laugh. “Now Grandma, my mom, I don’t know.” Her mother, she said, will probably sit back and say: “Isn’t that lovely. You missed a spot.”

Whether there would be a White House garden had become more than a matter of landscaping. The question had taken on political and environmental symbolism, with the Obamas lobbied for months by advocates who believe that growing more food locally, and organically, can lead to more healthful eating and reduce reliance on huge industrial farms that use more oil for transportation and chemicals for fertilizer.

Then, too, promoting healthful eating has become an important part of Mrs. Obama’s own agenda.

The first lady, who said that she had never had a vegetable garden, recalled that the idea for this one came from her experiences as a working mother trying to feed her daughters, Malia and Sasha, a good diet. Eating out three times a week, ordering a pizza, having a sandwich for dinner all took their toll in added weight on the girls, whose pediatrician told Mrs. Obama that she needed to be thinking about nutrition.

“He raised a flag for us,” she said, and within months the girls had lost weight.

Dan Barber, an owner of Blue Hill at Stone Barns, an organic restaurant in Pocantico Hills, N.Y., that grows many of its own ingredients, said: “The power of Michelle Obama and the garden can create a very powerful message about eating healthy and more delicious food. I don’t think it’s a stretch to say it could translate into real change.”

While the Clintons grew some vegetables in pots on the White House roof, the Obamas’ garden will far transcend that, with 55 varieties of vegetables—from a wish list of the kitchen staff— grown from organic seedlings started at the Executive Mansion’s greenhouses.

The Obamas will feed their love of Mexican food with cilantro, tomatillos and hot peppers. Lettuces will include red romaine, green oak leaf, butterhead, red leaf and galactic. There will be spinach, chard, collards and black kale. For desserts, there will be a patch of berries. And herbs will include some more unusual varieties, like anise hyssop and Thai basil. A White House carpenter, Charlie Brandts, who is a beekeeper, will tend two hives for honey.

The total cost of seeds, mulch and so forth is $200, said Sam Kass, an assistant White House chef, who prepared healthful meals for the Obama family in Chicago and is an advocate of local food. Mr. Kass will oversee the garden.

The plots will be in raised beds fertilized with White House compost, crab meal from the Chesapeake Bay, lime and green sand. Ladybugs and praying mantises will help control harmful bugs.

Cristeta Comerford, the White House’s executive chef, said she was eager to plan menus around the garden, and Bill Yosses, the pastry chef, said he was looking forward to berry season.

The White House grounds crew and the kitchen staff will do most of the work, but other White House staff members have volunteered.

So have the fifth graders from Bancroft. “There’s nothing really cooler,” Mrs. Obama said, “than coming to the White House and harvesting some of the vegetables and being in the kitchen with Cris and Sam and Bill, and cutting and cooking and actually experiencing the joys of your work.”

For children, she said, food is all about taste, and fresh and local food tastes better.

“A real delicious heirloom tomato is one of the sweetest things that you’ll ever eat,” she said. “And my children know the difference, and that’s how I’ve been able to get them to try different things.

“I wanted to be able to bring what I learned to a broader base of people. And what better way to do it than to plant a vegetable garden in the South Lawn of the White House?”

For urban dwellers who have no backyards, the country’s one million community gardens can also play an important role, Mrs. Obama said.

But the first lady emphasized that she did not want people to feel guilty if they did not have the time for a garden: there are still many changes they can make.

“You can begin in your own cupboard,” she said, “by eliminating processed food, trying to cook a meal a little more often, trying to incorporate more fruits and vegetables.”

Click here to read the original article.

© New York Times March 18, 2009 By: Marian Burros

Homeopathy for food allergies: Treatment for Peanut Allergies Shows Promise

A March 15 article in the New York Times, " Treatment for Peanut Allergies Shows Promise," talks about the practical applications of homeopathy. Although the article does not use the term homeopathy specifically, it does describe a study in which the treatment for a peanut allergy "uses doses of peanuts that start as small as one-thousandth of a peanut and eventually increase to about 15 peanuts a day."

The article then goes on to describe how in a pilot study at Duke University and Arkansas Children’s Hospital in Little Rock, "33 children with documented peanut allergy have received the daily therapy, which is given as a powder sprinkled on food. Most of the children are tolerating the therapy without developing allergic reactions, and five stopped the treatment after two and a half years because they could now tolerate peanuts in their regular diet. But four children dropped out because they could not tolerate the treatment."

The article cautions that this specific treatment for peanut (and other food-related allergies) is not ready for home use, yet homeopathics have been in the U.S. since the 19th century, according to the National Center for Complementary and Alternative Medicine.

Homeopathy is based on the principle of "like cures like," and involves, "giving extremely small doses of substances that produce characteristic symptoms of illness in healthy people when given in larger doses," (NCCAM).

Three main concepts of homeopathy include:

1. Homeopathy stimulates the body's defense mechanisms and processes to prevent/treat illness.

2. Treatment involves giving very small doses of substances called remedies that, according to homeopathy, would produce the same or similar symptoms of illness in healthy people if they were given in larger doses.

3. Treatment in homeopathy is individualized (tailored to each person). Homeopathic practitioners select remedies according to a total picture of the patient, including not only symptoms but lifestyle, emotional and mental states, and other factors.

Homeopathy training is often completed as part of a naturopathic training, and individual courses can be taken to adjunct to another holistic health practice, such as holistic health practitioner or nutritionist. In addition, with accredited holistic health training, there is growing opportunity to work in the complementary alternative medicine field, to provide whole person care.

For more information about homeopathy training, go to: http://www.achs.edu/course-desc.aspx?pid=24&id=4

For more information about studies involving peanut treatments for peanut food allergies, go to: http://www.nytimes.com/2009/03/16/health/16peanuts.html?_r=1&scp=1&sq=peanut&st=cse

To read more about homeopathy, visit the NCCAM website at: http://nccam.nih.gov/health/homeopathy/

Protect CAM and Health Freedom: HealthRevolutionPetition.org

Health freedom is one of the primary challenges faced by the U.S. today. Though we aren't all suited for frontline politics, the health freedom fight does not have to be all or nothing. There are many ways we can influence, and accomplish, change from our homes and from within our communities. Such as:

1. Ask your employer about natural medicine insurance alternatives.

2. Honor and protect your personal health first.

3. Be a grassroots promoter: Scour your community for the services you want. If they don't exist, ask for them. If they do exist, help to promote natural medicine and CAM services, and the longevity of the businesses that provide them.

4. Support community wellness education.

5. Familiarize yourself with health freedom laws in your state.

6. Help HealthRevolutionPetition.org to reach their goal of 100,000 signatures.

HealthRevolutionPetition.org is a new, grassroots petition that demands revolutionary changes to the health care system in America. It includes reforms of the FDA, drug company advertising, school lunch programs, coverage of natural therapies, and much more. See it and sign it online at HealthRevolutionPetition.org.

Maca: new insights on an ancient plant

The author [of the article "Maca: new insights on an ancient plant," T. Hudson], a naturopathic physician and professor at the Natural College of Naturopathic Medicine in Portland, Oregon, reviews the Peruvian herb maca (Lepidium peruvianum), which she has been prescribing for more than 15 years for common perimenopausal and menopausal symptoms. She examines the different types of maca, history of maca research, the health benefits of maca, and clinical evidence of its efficacy.

The maca species L. meyenii grows all over several South American countries, but the recently differentiated Peruvian maca species L. peruvianum grows only in Peru. In the early 1960s, Peruvian scientist, Gloria Chacón, PhD, presented a dissertation on maca root, which led to the eventual identification of over a dozen different Peruvian maca phenotypes as well as identification of the regions in Peru where these phenotypes grow. L. peruvianum has 13 different phenotypes corresponding to different colors, some of them containing unique DNA profiles and distribution patterns of active constituents, says the author.

Earlier, in 1843, the species L. meyenii had been described by botanist Gerhard Walpers. However, Dr. Chacón suggested, and herbalists around the world have agreed, that the cultivated maca of Peru (L. peruvianum) is a unique species. L. peruvianum is now accepted by many as the species name for medicinal maca from Peru. Though it may be confusing, says the author, "it is critical for a practitioner to investigate the source of the maca used as from Peru and/or ensure it is identified and labeled as L. peruvianum."

Maca has been found to be rich in minerals (with high concentrations of calcium, magnesium, iron, sodium, silica, manganese, copper, zinc, vanadium, and others) and also contains thiamine, riboflavin, ascorbic acid, proteins, carbohydrates, lignans, glucosinolates, phytosterols, and alkaloids.1 The alkaloids in its root are believed largely responsible for its traditional healing use, possibly benefiting the endocrine and reproductive systems by influencing such disorders as chronic fatigue, anemia, and infertility, and aiding in enhanced stamina and "female hormone balance."1

Traditionally used as an adaptogenic plant, maca aids the body in dealing with physiological, biochemical, and psychological stressors. Its adaptogenic properties represent an alternative approach to managing symptoms of menopause, says the author. Researchers theorize that maca stimulates hormonal reserves by strengthening the body's ability to regain and maintain hormonal homeostasis in the face of stressors.2 Other adaptogens have been used by herbal and alternative practitioners for years, but the extent of maca's effects on the range of menopausal symptoms has not been documented in studies of these other adaptogenic herbs. According to the author, this suggests that maca may be unique in its adaptogenic menopausal effects.

The author cites research on perimenopausal and menopausal women using two grams daily of a proprietary maca product (Maca-GO™; Natural Health International; San Francisco, CA), which found that maca can increase the body's production of estrogen and lower its levels of cortisol and adrenocorticotropic hormone. It also helped alleviate numerous menopausal symptoms including hot flashes, insomnia, depression, and nervousness.2 Other research cited, which was conducted on the composition of various powdered preparations of maca root, reported that the herb does not contain plant estrogen or hormones. Some researchers suggest that maca's therapeutic actions rely on plant sterols stimulating the hypothalamus, pituitary, adrenal, and ovarian glands, and therefore also affecting the thyroid and pineal glands.3 As such, says the author, maca tends to treat menopausal symptoms as a whole and not any one specific menopausal symptom.

The author reports that the most common symptoms of menopause she sees in her patients are hot flashes, mood swings, and low energy. She prescribes Maca-GO, one gram twice a day, for perimenopausal and postmenopausal patients, and reports an onset of benefits within two to three weeks, although some patients require treatment for two to three months (depending on the patient's overall health and prior prescription history). Benefits include a remarkable reduction in the number of hot flashes, an overall improvement in mood (less depression and irritability), and increased energy levels.

Much research is still needed, says the author, to clarify the role of exogenous estradiol (via prescription) versus endogenous estradiol (produced by the body) in general, and, specifically, for patients in whom exogenous estrogen is questionable or even contraindicated. With confusion and inconsistency looming over the benefits and risks associated with hormone replacement therapy, "it behooves us to seek the lowest dose and the most gentle, least invasive approach to achieve the identified goals—whether these be relief of symptoms, prevention of bone loss, or protection of cardiovascular health," writes the author. Maca research should influence the optimal strategy for treating the symptoms of menopause, especially when trying to minimize unnecessary long-term exposure to exogenous estrogens.

The author also includes a sidebar on current supply issues relating to the commercial use of maca. "Some of the product previously and currently available in the United States may contain less than a therapeutically useful dose" and "may not contain the appropriate combination of phenotypes to elicit the desired gender-, age-, and symptom-related physiological responses, or the product may simply contain the wrong plant." She recommends that practitioners check into the ethics of the companies selling and manufacturing maca products.

References

1Chacon G. Maca (Lepidium peruvianum Chacon). 1st ed. Lima, Peru: Grafica Mundo; 2001.

2Meissner HO, Mscisz A, Reich-Bilinska R, et al. Hormone-balancing effect of pre-gelatinized organic maca (Lepidium peruvianum Chacon): (III) Clinical response of early-postmenopausal women to maca in a double blind, randomized, placebo-controlled, crossover configuration, outpatient study. Int J Biomedical Sci. 2006;2(4):375-394.

3Walker M. Effect of Peruvian maca on hormonal functions. Townsend Lett. Nov 1998:18-22.

Review by Shari Henson. © HerbClip 2009: http://cms.herbalgram.org/herbclip/371/review020391-371.html

RE : Hudson T. Maca: new insights on an ancient plant. Integrative Med. Dec 2008/Jan 2009;7(6): 54-57.

Should the FDA have more regulation over dietary supplements?

Following the release March 2, 2009, by the U.S. Government Accountability Office (GAO) of a report on the oversight and regulation of dietary supplements (FDA Should Take Further Actions to Improve Oversight and Consumer Understanding), the Natural Products Association (NPA) released the following statement from Executive Director and CEO David Seckman.

"The Natural Products Association appreciates having the opportunity to be included in the GAO's review of dietary supplement regulation, particularly regarding the recent implementation of adverse event reporting and good manufacturing practices. Our initial impressions regarding the four key recommendations of the report are as follows.

"Contrary to opinions stated in the report, the FDA already has a great deal of information about individual dietary supplement products and their manufacturers. The dietary supplement industry has cooperated by registering all manufacturing facilities under bioterrorism regulations that went into effect more than five years ago. Additionally, the NPA is currently working with the government to create a database of all dietary supplement labels to augment this information.

"We also take issue with the implication that the FDA has limited power to remove products from the marketplace. In fact, although the agency has had scant reason to do so, it has exercised its ability to take products off the shelves it deemed a health risk.

"While we supported legislation to establish mandatory adverse event reporting for dietary supplements and over-the-counter drugs, we still believe that reporting should be limited to incidents that are serious. If the FDA's resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense.

"We support further guidance clarifying how the FDA determines when an ingredient is considered 'new' to the marketplace and what evidence is needed to document safety. Likewise, we are in favor of the agency clarifying when it believes products should be marketed as conventional foods versus dietary supplements.

"One of the fundamental principles of DSHEA [Dietary Supplement Health and Education Act of 1994] is providing consumers with more information so that they can make informed decisions to maintain and improve their health. So we are in agreement that the FDA should work with stakeholder groups to educate consumers about the safety, efficacy and labeling of dietary supplements.

"There is little scientific data regarding underreporting of adverse events and the data that are cited are not specific to dietary supplements, but represent all FDA-regulated products, including pharmaceuticals, a category that accounts for more than 460,000 reports annually.

"As we told the GAO, we believe regulations governing the manufacturing of dietary supplements enhance the FDA's ability to ensure the safety and purity of these products. These long-awaited regulations, more than 12 years in the making, were greeted with enthusiasm from industry. Likewise, the industry supported the law establishing mandatory adverse event reporting for dietary supplements. However, we disagree with some aspects of how the FDA has implemented this law. Specifically, we told the GAO the following:

1. The changes to dietary supplement regulation exceed the mandate of the law, especially in regarding to prefatory warning language on product labels.

2. The substantial added expenses to dietary supplement manufacturers to redesign and replace their product labels due to the AER law, upwards of $200 million according to the FDA's own estimates, should have been proposed through a formal rulemaking process, not a guidance. Additionally, the FDA is not allowing adequate time for manufacturers to re-label their products in this case, only one year. Previous regulations of this magnitude have allowed manufacturers a reasonable three years to implement label changes.

We are also concerned about the availability of adverse event reports submitted to the agency and how they will be reported to the public . This has yet to be adequately addressed by the FDA.

"As we have in the past, the association supports adequate funding for the FDA to do its job in regulating dietary supplements. This includes fully implementing the law, DSHEA, and taking appropriate enforcement action against those who break it."