Herbs, BlurbsNaturally Were Confused! Straight Talk About Women and Dietary Supplements

Breakfast Seminar - January 23, 2001

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Jury Still Out on Safety, Efficacy of Botanicals

Despite Americans enthusiasm for herbal and other dietary supplements, the safety and efficacy of many such products remain unconfirmed. However, efforts are underway to conduct better research, establish industry standards, and provide more information to consumers and health care practitioners. Rebecca Costello, PhD, deputy director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, and Linda Golodner, president of the National Consumers League (NCL), delivered that cautiously optimistic message at a Jacobs Institutes breakfast seminar January 23 in Washington, DC.

Dr. Costello described the origins of the ODS, which was formed by a mandate from the U.S. Congress as part of the Dietary Supplement Health and Education Act (DSHEA) of 1994. The ODS collects scientific information on supplements and advises other government agencies. Sales of dietary supplements, a category that encompasses a range of products from vitamins to herbal compounds, reached $14.9 billion in 1999, according to Dr. Costello. Although some evidence for supplementation is strong and forms the basis of national health recommendations, such as the Institute of Medicines dietary reference intakes for calcium and iron, much of the available science on botanical products varies in quality, sometimes raising more questions than it answers.

While proponents of supplements point to a long historysometimes thousands of yearsof safe consumer use in Asia, Europe, and elsewhere, American consumersparticularly consumer watchdog organizationsdemand more and better-conducted research to address concerns about safety, particularly the potential interactions of supplements with prescription medications, over-the-counter products, and even other supplements. Much of the evidence that botanicals work comes from what are considered the weakest types of research, including anecdotal reports and case studies, said Dr. Costello.

Dr. Costello described some of the most commonly used herbal supplements:

For premenstrual syndrome

Chaste tree berry/chaste berry

Evening primrose oil

For symptoms related to menopause

Phytoestrogens (soy and red clover)

Black cohosh

Don quai/Angelica (root)

Wild yam

For depression

St. Johns wort

For weight loss

Ephedra/ma huang

Conjugated linoleic acid

Green tea

For breast cancer

Soy products

Her explanation of the current understanding of specific supplements underlined the concerns many have about using such products. For example, although good evidence shows St. Johns wort is effective in treating depression, "The mechanism of action still has not been determined," said Dr. Costello, and recent reports suggest it may make oral contraceptives and HIV drugs less effective.

While many believe soy products may relieve symptoms of menopause, "Randomized, controlled trials to date show mixed results," said Dr. Costello, and different forms of soy have been used in the trials, making the findings difficult to compare. A recent workshop at the National Institute on Aging concluded further research is needed before soy can be recommended, including study on how soy isoflavones interact with a womans own stores of estrogen, noted Dr. Costello.

The NIH is actively supporting and funding research on supplements through the ODS, the National Center for Complementary and Alternative Medicine, the Office of Research on Womens Health, and the National Cancer Institute, among others. Four centers for botanical research at prominent universities across the country have received substantial government funding: Columbia University, Purdue University, the University of Chicago, and the University of California, Los Angeles. Results from some supplement studies should be available "in the next few years," said Dr. Costello.

The NCL, said Ms. Golodner, was established in 1899 to root out "snake-oil" remedies and continues to work on behalf of consumers to identify fraud in everything from financial services to health care. The group brought together dietary supplement industry leaders, including manufacturers and retailers, with government representatives and consumer advocates in two roundtable discussion over the past two years.

Not surprisingly, her group found the industry "feels there is enough regulation of supplements but not enough enforcement of existing laws," said Ms. Golodner. They believe the government should work harder to get unsafe products or those making unsubstantiated claims off the market. Yet, she noted, industry representatives support the creation of Good Manufacturing Practices (GMPs) and standards for dietary supplements by the Food and Drug Administration (FDA).

Another roundtable discussion with the FDA concluded more independent research on quality, standardization, GMPs, and testing is needed. In addition, participants concluded they need to better publicize information about unsafe products or those making unapproved (ie, unsubstantiated) claims to cure disease.

The NCL surveyed consumers and health care practitioners about dietary supplements in 1999. The consumer group included over 1,000 adults and over 2,000 children in grades 712 and found children are more likely to get product information from the Internet and television, while adults tend to read print advertising and package labeling. Both groups, however, depend heavily on the advice and recommendation of family and friends. Interestingly, another survey (www.pewinternet.org) found 55% of people with Internet access used the web to get health or medical information, and women are more likely than men to seek health information online.

The NCL survey found, "Most middle-aged women (4/5) take herbal remedies and dietary supplements, prescription drugs, or both to prevent or treat health conditions associated with aging," said Ms. Golodner. Many also have almost as much confidence in the safety of botanical and dietary supplements (66%) as they do in prescription drugs (85%), but 34% believe the FDA regulates supplements in a manner similar to prescription drugs.

Many women do not tell their doctors they use supplements. Ms. Golodners study found about half (52%) feel their health care provider would be against their use of supplements, 43% feel the supplements "seem safe and dont need to be discussed," and 37% "assume remedies are effective."

Among the doctors surveyed, 57% believe supplements are beneficial but they acknowledge they do not always advise their patients about them, nor do they talk with patients about potential side effects and interactions. The survey concluded communication between health care providers and patients about supplements needs to improve and health care providers need more information about supplements, including safety, efficacy, and potential interactions.

Wyeth-Ayerst, Inc., provides support for the Jacobs Institutes breakfast seminar series.

CONSUMER TIPS ON DIETARY SUPPLEMENTS

  • "Natural" does not always equal "safe."
  • Tell your health care provider what supplements you take.
  • Use extreme caution when taking large doses of single nutrients or botanicals, because they may interact with other drugs or supplements.
  • If you take a supplement, consider taking a multivitamin/mineral complex that falls in line with recommended dietary allowances (RDAs).
  • Be critical of the evidence; many studies on supplements are short, have a small number of patients, focus on select groups of patients, or use formulations that vary from study to study.
  • Before going to your health care provider, write down some issues youd like to discuss, including questions about supplements.
  • If necessary, seek out other staff in your health care providers office, eg, a nurse or dietitian, who may have more time to talk about your specific questions.
  • Dont be afraid to bring articles, newspaper clippings, or other information about a supplement (or alternative therapy) to your provider and ask if you can discuss the information over the phone once the provider has had time to read it.

For a list of interesting links on dietary supplements Click Here