The University of Illinois at Chicago College of Pharmacy has received a $7.9 million grant from the National Institutes of Health to create one of the nation's first centers to research dietary supplements.
Despite the phenomenal surge in the popularity of botanical dietary supplements, little has been scientifically proven regarding their safety and effectiveness in humans.
"The supplements industry is not a research-based industry," said Norman Farnsworth, principal investigator and director of UIC's new Center for Dietary Supplements Research on Botanicals.
Complicating this situation is the lack of regulation in the supplements industry. Farnsworth, research professor of pharmacognosy, served on the presidential Commission on Dietary Supplement Labels, formed in 1995.
The UIC center initially will focus on women's health. Researchers will begin by studying 10 herbal supplements that are widely used by women in this country to treat conditions including menopausal symptoms, premenstrual syndrome and urinary tract problems. The center will work closely with UIC's Center of Excellence in Women's Health, a U.S. Health and Human Services-funded center established at the university in 1998.
The researchers point to the demand among women for botanicals to treat menopausal symptoms, the risks associated with estrogen replacement therapy, and the potential benefits of alternatives to estrogen replacement therapy as motivating factors in their decision to initially focus on women's health.
The 10 herbal supplements to be studied at UIC are:
Black Cohosh (Cimicifuga racemosa)Red Clover (Trifolium pratense)Chaste Berry (Vitex agnus-castus)Hops (Humulus lupulus)Dong Quai (Angelica sinensis)Asian Ginseng (Panax ginseng)Gingko (Ginkgo biloba)Licorice (Glycyrrhiza glabra)Cranberry (Vaccinium macrocarpon)Valerian (Valeriana officinalis)
The researchers said they selected these botanicals because anecdotal evidence and preliminary studies suggest that they are safe and effective and, therefore, good candidates for human studies.
Another reason is that there is little or no scientific research upon which to determine safe and effective dosages and, thus, formulate standardized preparations.
Additionally, there is little or no scientific research explaining how the botanicals work or identifying their active principles.
Native American women for centuries have used Black Cohosh, for example, to alleviate a variety of common health complaints of women. European clinical and case studies suggest that an extract of the botanical may be safe and effective in alleviating menopausal symptoms, but these studies have some weaknesses, Farnsworth, said.
"Even though these studies are not without criticism, when you get a critical mass such as this you have to say where there's smoke, there probably is fire," he said.
The multidisciplinary UIC research team includes experts from pharmacognosy, medicinal chemistry, pharmacy practice, obstetrics and gynecology, geriatrics, surgical oncology, and mathematics and statistics. The co-director of the center is Richard B. van Breemen, associate professor of medicinal chemistry and pharmacognosy. The researchers will study two botanicals each year.
They will begin by determining what kind of extract they are going to use. They will identify the active compounds from the extract and formulate a standardized preparation. A supplements maker will manufacture both a placebo and supplement, based on the UIC team's method and formulation. Researchers will determine the mechanism of action in the test tube of both the extract and the pure compound. They also will study in the test tube how the compound is metabolized. At the end of this nine-month period of bench research, UIC physicians will study the safety and efficacy of the compound in phase I and phase II human trials.
"The UIC group put together an interdisciplinary team and proposed a systematic approach to evaluating the safety and efficacy of herbal products through both basic research and clinical studies," said Christine Swanson, program director of the Dietary Supplements Research Centers in the NIH Office of Dietary Supplements. "This group has an outstanding research, teaching and training background in the area of herbs for medicinal uses. We hope our funding of the UIC center and its work will generate additional private and public support for this important area of research."
The UIC Center for Dietary Supplements Research on Botanicals also will emphasize education and outreach.
"To address the complex issues associated with botanicals, one must first have highly trained professionals with expertise in pharmacognosy [the study of botanical, chemical, biochemical, pharmacological, and economic aspects of natural products and primarily plants]," Farnsworth said. "But one of the major stumbling blocks to the advancement of botanical science in the United States is the lack of adequately trained Ph.D.-level scientists needed to address the issues related to quality, safety and efficacy of botanical supplements."
The new center will enable the UIC College of Pharmacy to offer more opportunities for graduate students to specialize in botanical supplements and for post-doctoral professionals to receive training in this field.
"Education in botanical supplements at this level is desperately needed," said Gail Mahady, research assistant professor and co-investigator with Farnsworth of the center's Education and Outreach Core. "So many pharmaceutical companies are interested in researching and developing botanicals, but they can't find enough highly-trained pharmacognosists."
The center also will develop online continuing education programs in botanical supplements for pharmacists and other health professionals.
The researchers will transform the College of Pharmacy's Natural Products Alert database - a database of world literature on plants, microbes and marine organisms - into an interactive Web site that is accessible to consumers and health professionals. They will work with pharmacists in the college's Drug Information Center to build on the information center's expertise in botanical dietary supplements. The information center offers a free telephone information line used by consumers, pharmacists and other health care professionals, and pharmaceutical researchers who want information about prescription and over-the-counter medications.
With 11 professors of pharmacognosy, UIC's College of Pharmacy has the largest pharmacognosy group in the United States. It enjoys an international reputation as a center for the study of biologically active natural products. The group's stature stems in part from its plant exploration and collection programs, focused on drug discovery, and its extraordinary success in isolating and identifying compounds from plants with high potential as candidates for drug development.
With 25,000 students, the University of Illinois at Chicago is the largest and most diverse university in the Chicago area. UIC is home to the largest medical school in the United States and is one of the 88 leading research universities in the country.
The above story is based on materials provided by University Of Illinois At Chicago. Note: Materials may be edited for content and length.
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