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Investigating the Science Behind Plants as Treatments
Plants and their products, which together are called botanicals, make up an important research area for NCCAM. Examples of botanicals are flowers, leaves, bark, fruits, seeds, stems, and roots; exudates (that is, substances emitted by plants); and algae. About 25 percent of the economic market for dietary supplements in America consists of botanicals. For the most part, botanicals have not been rigorously studied. Even though many of them have been used for centuries, there are many reasons to study them now. For example, some botanicals may be toxic. Some have been found to interact with other botanicals or with medications (whether prescription or over-the-counter). Often the ingredient(s) that are active medicinally in a botanical are unknown or not well understood. "Our research portfolio in botanicals covers a wide range—from laboratory-based research studying their effects on the body to large clinical trials testing their safety and effectiveness in people," says NCCAM Director Stephen E. Straus, M.D. "Exploring how and why botanicals act in the body is a key step in evaluating their safety and effectiveness."
Recent NCCAM-sponsored research has led to important insights about botanicals on:
In fiscal year 2003, NCCAM spent $24.8 million on research related to botanicals. This fiscal year, 2004, research on botanicals continues to be a very active area. Some highlights are described below. Botanical Research CentersNCCAM sponsors a Botanical Research Centers (BRCs) Program in partnership with the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and the National Institute of Environmental Health Sciences (NIEHS). Currently, there are five BRCs cofunded by NCCAM (to find out more, go to nccam.nih.gov/training/centers and scroll down to "Centers for Dietary Supplements Research: Botanicals"). Investigators at these centers are working to "characterize" botanicals, or define their chemical and biological characteristics as completely as possible. This is important to achieve before a botanical product is tested in a clinical trial (a research study in people). The botanical products tested in clinical trials need to be as stable and consistent as possible in their composition and actions in the body in order for trial results to be most meaningful. Among the challenges in studying botanicals is that it is difficult to make botanical products so that every batch is fairly similar. Active ingredients in the same species of plant can vary widely depending on such factors as where the plant is grown, when it is harvested, how it is prepared, and how it is stored. In December 2003, NCCAM (with ODS and NIEHS) issued a request for applications to form new centers, following the recommendations of an expert panel that reviewed the BRCs Program in 2003 (more at nccam.nih.gov/training/centers/bot-research-index.htm). Cranberry ResearchNCCAM is supporting a research initiative to study cranberry for the prevention and treatment of urinary tract infections, other infections, and other conditions for which there has been promising early evidence. In February 2002, NCCAM released a solicitation for research-grade cranberry products to be developed for use in NIH-sponsored studies. The selected contractor is developing a cranberry powder in capsules, a cranberry juice cocktail, and a matching placebo for each. While these materials were being developed, in February 2003 NCCAM requested cranberry research project applications. As of February 15, 2004, nine grants had been awarded—two to find out more about how cranberry behaves in the body and interacts with drugs, two on its basic science, four on its use to prevent urinary tract infections, and one on its use against dental plaque. The cranberry initiative is being cosponsored by NCCAM, ODS, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Dental and Craniofacial Research. Phase III Clinical TrialsPhase III clinical trials sponsored by NCCAM are progressing on three botanicals: Ginkgo biloba for preventing Alzheimer's disease, St. John's wort for treating minor depression (cosponsored with the National Institute of Mental Health and ODS), and saw palmetto for relieving symptoms of prostate enlargement (cosponsored with NIDDK). International CollaborationsAnother key area is international collaborations. In September 2003, NCCAM launched a new program by awarding 10 Planning Grants for International Research Centers on Complementary and Alternative Medicine (CAM). These grants are establishing global collaborations and cross-cultural exchange among international and U.S. institutions to design and implement research on CAM approaches—including botanicals—from traditional medical systems, such as those of China, India, and Korea. Additional ProjectsNCCAM's portfolio includes additional projects on botanicals—such as garlic (a CAM therapy commonly used by patients with HIV/AIDS) and how it interacts with antiretroviral medications; plants traditionally used by Native Americans to treat tuberculosis; feverfew, for its potential usefulness against migraines; and borage oil, for its potential benefits in rheumatoid arthritis. "NCCAM recognizes the potential of botanicals and is committed to their rigorous research," says Dr. Straus. "Ultimately, the public will benefit as we discover which botanicals are safe and effective—and which are not." Sources Ervin RB, Wright JD, Kennedy-Stephenson J. Use of dietary supplements in the United States, 1988-94. Vital and Health Statistics Series 11. 1999;(244):i-iii, 1-14. Markowitz JS, Donovan JL, DeVane CL, et al. Effect of St John's wort on drug metabolism by induction of cytochrome P450 3A4 enzyme. Journal of the American Medical Association. 2003;290(11):1500-1504. Project concept review: Botanical Research Centers Program. National Center for Complementary and Alternative Medicine Web site. Accessed on March 8, 2004. Taylor JA, Weber W, Standish L, et al. Efficacy and safety of echinacea in treating upper respiratory tract infections in children: a randomized controlled trial. Journal of the American Medical Association. 2003;290(21):2824-2830. Wadsworth T, Poonyagariyagorn H, Sullivan E, et al. In vivo effect of PC-SPES on prostate growth and hepatic CYP3A expression in rats. Journal of Pharmacology and Experimental Therapeutics. 2003;306(1):187-194. Zhang DY, Wu J, Ye F, et al. Inhibition of cancer cell proliferation and prostaglandin E2 synthesis by Scutellaria baicalensis. Advances in Cancer Research. 2003;63(14):4037-4043. For more information on botanical supplements, go to nccam.nih.gov/health/supplement-safety/herbal-supplements.htm or contact the NCCAM Clearinghouse. Celebrating 5 Years, NCCAM Invites Your Input on Strategic PlanningIn 1999, the U.S. Congress established NCCAM at the National Institutes of Health. NCCAM celebrates its fifth anniversary in 2004. As part of that celebration, the Center has launched a strategic planning initiative to establish its vision and goals for the years 2005 to 2009. All stakeholders (the public, health care professionals, researchers, and others) are invited to be part of this planning process. Here are the ways you can participate:
NCCAM's first strategic plan set out a vision and plans for the years 2001 to 2005 (see nccam.nih.gov/about/plans/fiveyear). The Center now seeks to build on its achievements, refine its goals, and prioritize its investments to realize the greatest success and impact in the upcoming years. The first public events in the strategic planning process were NCCAM's two Stakeholder Forums. The first was held on March 22, 2004, in Bethesda, Maryland; at press time, the second is scheduled for April 19, 2004, in Seattle (nccam.nih.gov/about/plans/2005). Five Years卆nd Counting Stephen E. Straus, M.D., Director of NCCAM, announced the new strategic planning effort during his annual State of the Center Address on January 30, 2004. He also recounted the Center's accomplishments from 1999 to the present. Among those accomplishments:
"Above all," Dr. Straus said, "NCCAM research findings have begun to have an impact on public policy, on choices made by patients, and on clinical practice. As we move ahead, our primary goals will continue to be maintaining an open and objective approach to CAM research and communicating those research results to our stakeholders." Elias A. Zerhouni, M.D., NIH Director, praised NCCAM at its fifth-year anniversary for "5 years of stellar work and aggressively mapping the future of the field through strategic planning."
Calendar of EventsThis calendar lists events on complementary and alternative medicine (CAM) that are sponsored or organized by NCCAM or other components of NIH, and includes information available at press time. For more information, go to nccam.nih.gov or call the NCCAM meeting line at 301-594-9632. June 2004 Telephone Educational Workshop: June 22, 1:30�30 p.m. ET. "An Overview of Complementary and Alternative Medicine and Cancer." Speaker: Stephen E. Straus, M.D., NCCAM Director. Designed for people with cancer and their family and friends, this workshop is a collaboration between NCCAM, Cancer Care, Inc., and the American Society for Clinical Oncology. Participants will listen by telephone, and both registration and the telephone call are free. To register, go to www.cancercare.org or call 1�0�3�73. The workshop will be archived at www.cancercare.org. Other InformationNCCAM Director Stephen E. Straus, M.D., is senior author of "Ethical Issues Concerning Research in Complementary and Alternative Medicine" in the February 4, 2004, issue of the Journal of the American Medical Association. To view an abstract of the article, as well as other items by and about Dr. Straus, visit the new "Director's Corner" on NCCAM's Web site, at nccam.nih.gov/about/offices/od/straus.htm. On February 6, 2004, the U.S. Food and Drug Administration (FDA) issued a "final rule" prohibiting the sale of dietary supplements containing ephedra (ephedrine alkaloids). This rule is to take effect on or about April 6, 2004. The FDA also advised consumers to stop using these supplements, finding them to carry an unreasonable risk of illness or injury (more at www.fda.gov). An NCCAM Consumer Advisory on ephedra is available at nccam.nih.gov/news/alerts/ephedra/consumeradvisory.htm. The Congressional Justification 2005 is available on the NCCAM Web site at nccam.nih.gov/about/budget/congressional/. This document, prepared each year for the consideration of the U.S. Congress, outlines NCCAM's plans and priorities for fiscal year 2005 (which begins October 1, 2004) and includes details of the proposed budget, a legislative history, and other items.
News for ResearchersVisit nccam.nih.gov/cgi-bin/grants/funding.pl for more information on these and other NCCAM funding opportunities.
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